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Trial registered on ANZCTR
Registration number
ACTRN12624000918527p
Ethics application status
Not yet submitted
Date submitted
1/07/2024
Date registered
29/07/2024
Date last updated
29/07/2024
Date data sharing statement initially provided
29/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Fluorodeoxyglucose (FDG) and human epidermal growth factor receptor 2 (HER2) positron emission tomography (PET) scan in breast cancer
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Scientific title
Appraising the utility of whole tumour heterogeneity assessment by novel HER2 PET scanning compared to standard-of-care FDG-PET scanning in metastatic breast cancer
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Secondary ID [1]
312403
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2024/GR000912
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Universal Trial Number (UTN)
U1111-1309-8481
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast cancer
334213
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Condition category
Condition code
Cancer
330878
330878
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be asked to fast for a few hours before the FDG- and HER2-PET scans. If participants are diabetic, they will be given instructions about their diabetes medications and their blood sugar will be checked upon arrival at the hospital.
Participants will be asked to undergo a standard-of-care FDG-PET scan and a novel HER2-PET scan at baseline in the Nuclear Medicine Department at Fiona Stanley Hospital. Each scan will occur on different days within 1 week. We will ask participants to wait a minimum of 24 hours between scans. It is expected that the entire procedure will take 2-3 hours per scan. The entire procedure will be conducted by Radiologists and Nuclear Medicine physician's and their team.
The Australian Diagnostic Reference Level (DRL) for standard FDG-PET imaging is 3.5 MBq/kg (for patients weighing between 50 and 120 kg). The 68Gallium-HER tracer will be administered at a dose of 107MBq.
As participants will have HER2 positive or HER2 low metastatic breast cancer, baseline will be prior to treatment with the antibody-drug conjugate trastuzumab-deruxtecan (T-Dxd).
The HER2-PET scan uses gallium-labelled HER2 binding peptides that have an affinity for the HER2 receptors which are present in many breast cancers. The radio-isotope injection (HER2 or FDG) is administered via a needle (cannula) into a vein in the hand or arm. Following this, participants will undergo positron emission tomography (PET). This involves participants entering a PET scanner for approximately 20 minutes.
Upon disease progression based on RECIST criteria, participants will be asked to undergo a second FDG-PET and HER2-PET scan. After these second scans, this will be the end of the study for participants with progressive disease. Treating clinicians will determine further monitoring appropriate for each individual.
Participants with stable disease throughout the study will return to standard follow-up imaging as determined by the treating clinician and this will be the end of the study.
For those with HER2 avid but FDG-PET non-avid disease with known visceral disease, CT scan will also be performed
It is anticipated that the study will take 1 year from the date of recruitment.
As this is a PET scan study, there is no requirement for adherence to an intervention. However, we will monitor scan attendance and record results in electronic medical records.
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Intervention code [1]
328908
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Diagnosis / Prognosis
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Comparator / control treatment
Controlled. The novel HER2-PET scan will be compared to the standard-of-care FDG-PET scan, and as such the FDG-PET scan constitutes the comparator/control treatment in this study.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility of HER2-PET scanning.
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Assessment method [1]
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We will evaluate the clinical feasibility of HER2-PET scans in terms of getting interpretable images by a qualitative assessment. An overall image quality score will be rated on a 4-point scale: 1 excellent, 2 good, 3 poor but interpretable, 4 poor non-interpretable. In addition, a spherical volume of interest (~100 cm3) will be defined in a uniform area of each patient’s liver. Patients with liver metastasis or any other hepatic pathology (i.e. steatosis, cirrhosis) will be discarded for noise evaluation.
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Timepoint [1]
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At time of first study scan.
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Primary outcome [2]
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Quantitative assessment of the clinical accuracy of each imaging modality.
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Assessment method [2]
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For quantitative analysis, a multimodality computer platform will be used to measure the distribution and intensity of FDG and HER2 uptake in potential tumour foci. The maximum standardized uptake value (SUVmax) normalized to body weight will be calculated by drawing a 3-dimensional volume of interest around each lesion identified by the FDG- and HER2-PET scans.
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Timepoint [2]
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At time of first study scan and any additional scans completed upon disease progression for 5 years post-enrolment.
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Secondary outcome [1]
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Disease activity detected on HER2-PET.
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Assessment method [1]
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Disease activity detected on HER2-PET will be assessed by measuring the distribution and intensity of HER2 uptake. The maximum standardized uptake value (SUVmax) normalized to body weight will be calculated by drawing a 3-dimensional volume of interest around each lesion identified by the HER2-PET scan. This will be used to determine the extent of suspected HER2 positive (including low and ultra-low) metastatic disease in cases of equivocal lesions on the standard workup. We will compare baseline FDG and HER2 scans to identify appearance of discrepancies. For those with HER2 avid but FDG-PET non avid disease with known visceral disease, CT scan will also be performed. Baseline and follow-up scans (where available) will be used to measure whether HER2 heterogeneity is a mechanism of relapse.
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Timepoint [1]
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At time of first study scan and any additional scans completed upon disease progression for 5 years post-enrolment.
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Secondary outcome [2]
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Clinical assessment of treatment response.
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Assessment method [2]
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Clinical assessment of treatment response will be assessed by measuring HER2 uptake determined by HER2-PET scan(s).
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Timepoint [2]
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At time of first study scan and any additional scans completed upon disease progression for 5 years post-enrolment.
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Eligibility
Key inclusion criteria
HER2 positive or HER2 low metastatic breast cancer patient as defined by immunohistochemistry (IHC) measuring cell membrane HER2 protein and/or by in situ hybridisation (ISH) measuring the number of HER2 genes in each cell nucleus. HER2 positivity is defined as either strong (3+) cell membrane staining by IHC or amplification of the HER2 gene by ISH. Participants must be T-Dxd treatment naïve in the metastatic setting. The number of HER2 positive and HER2 low participants included in the study will be capped at five each (e.g. 5 HER2 positive and 5 HER2 low).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Life expectancy less than 6 months, unable to give informed consent, unable to comply with required scanning schedule. May include conditions that increase the risk to the participant, that interfere with the participants ability to give informed consent or interfere with a participant’s ability to comply.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Efficacy parameters are 1) sensitivity, 2) specificity, 3) positive predictive value, and 4) negative predictive value.
Methods will be compared on a per-lesion and per-patient basis.
Pearson’s Chi-square test will be used to analyse categorical variables.
Continuous data will be expressed either as the mean with standard deviation (SD) of SUVmax or as the median with interquartile range (IQR) of SUVmax, as appropriate. The percentage coefficient of variation (COV) will be calculated as the SD divided by the mean and multiplied by 100.
The difference in qualitative scores between FDG and HER2-PET images or any other matched continuous variables will be evaluated using the Wilcoxon signed-rank test. Other continuous variables will be assessed using the relevant t-test. HER2-PET will be determined to be suggestive to have clinical utility if appearing superior to FDG-PET in >=20% of patients.
The correlation of SUVmax and HER2 scores will be calculated using Spearman’s rank.
All statistical tests will be two-sided with a significance level of p < 0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
27/01/2025
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Actual
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Date of last participant enrolment
Anticipated
2/02/2026
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Actual
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Date of last data collection
Anticipated
8/02/2027
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
42777
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Fiona Stanley Hospital
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Address [1]
316811
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Country [1]
316811
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Australia
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Primary sponsor type
Hospital
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Name
Fiona Stanley Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319041
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None
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Name [1]
319041
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Address [1]
319041
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Country [1]
319041
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
315581
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
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https://smhs.health.wa.gov.au/Our-research/For-researchers
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
315581
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15/08/2024
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Approval date [1]
315581
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Ethics approval number [1]
315581
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Summary
Brief summary
This study aims to investigate the usefulness of a new, experimental form of imaging known as HER2-PET (Human Epidermal Growth Factor Receptor 2 - Positron Emission Tomography) scanning in metastatic breast cancer. Who is it for? You may be eligible for this study if you are an adult female with HER2 positive or HER2 low metastatic breast cancer, and have not yet undergone treatment with the antibody-drug conjugate trastuzumab-deruxtecan (T-Dxd) in the metastatic setting. Study details Participants will be asked to undergo a standard-of-care FDG-PET (Fluorodeoxyglucose-PET) scan and a novel HER2-PET scan at baseline in the Nuclear Medicine Department at Fiona Stanley Hospital. These scans will each involve a radio-isotope injection followed by a 20-minute PET scan. Upon disease progression, participants will be asked to undergo a second FDG-PET and HER2-PET scan. Analysis of the imaging findings and treatment response to T-Dxd will be undertaken. It is hoped that findings from this study will help researchers determine the clinical utility of HER2-PET scanning for breast cancer imaging in Australia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Zeyad Al-Ogaili
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Address
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, Western Australia 6150
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Country
135146
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Australia
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Phone
135146
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+61 8 61525067
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Fax
135146
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Email
135146
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[email protected]
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Contact person for public queries
Name
135147
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Katie Meehan
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Address
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Harry Perkins Insistute of Medical Research (South), 5 Robin Warren Dr, Murdoch WA 6150
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Country
135147
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Australia
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Phone
135147
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+61 8 6151 1141
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Fax
135147
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Email
135147
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[email protected]
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Contact person for scientific queries
Name
135148
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Andrew Redfern
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Address
135148
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, Western Australia 6150
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Country
135148
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Australia
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Phone
135148
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+61 8 6151 1141
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Fax
135148
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Email
135148
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The de-identified participant data to be shared includes all individual participant data collected during the trial.
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When will data be available (start and end dates)?
Start date: June 2027
End date: July 2028
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Available to whom?
Clinical trial consented participants that have adhered to all inclusion and exclusion criteria. This is subject to approval by Principal Investigator Dr Al-Ogaili, Zeyad and institutional human ethics approval.
EMAIL:
[email protected]
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Available for what types of analyses?
Any protocol approved by the principal investigator and contingent on appropriate institutional ethics approvals.
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How or where can data be obtained?
By email from the principal investigator Dr Al-Ogaili, Zeyad.
EMAIL:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23988
Study protocol
388022-(Uploaded-12-07-2024-18-18-05)-HER2-PET Protocol v1 18 June 2024.doc
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF