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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05889728
Registration number
NCT05889728
Ethics application status
Date submitted
5/04/2023
Date registered
5/06/2023
Date last updated
5/06/2023
Titles & IDs
Public title
Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer
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Scientific title
Assessment of the Diagnostic and Theranostic Potential of Ga Bombesin PET/CT (NeoB) Imaging for Staging of ER/PR + HER2- Breast Cancer Patients With Metastatic Disease: Comparison to Conventional Imaging
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Secondary ID [1]
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Best TRial
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Universal Trial Number (UTN)
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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
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - [68Ga]GA-NeoB
Experimental: 68Ga Bombesin PET/CT (NeoB) imaging for staging breast cancer - All patients will undergo a single time point imaging at Day 0 with PET CT to be conducted 120 (+/- 30) minutes after intravenous administration with 68Ga NeoB (3.0MBq/kg or up to a maximum of 250 Mbq).
Treatment: Drugs: [68Ga]GA-NeoB
Is a positron emission tomography (PET) imaging agent, intended as a selection tool for [177Lu]Lu-NeoB treatment in patients with tumors overexpressing gastrin releasing peptide receptor (GRPR).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)
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Assessment method [1]
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Diagnostic accuracy will be assessed by comparing lesions found on 68Ga NeoB PET CT to lesions found on conventional imaging (including CT, bone scan, and 18F-FDG PET/CT). Correlating images by sensitivity, specificity, true positive and negative predictive value
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Comparison of SUVmax/mean
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Assessment method [1]
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To compare SUV max/mean of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Quantitative Variation in Lesion measuring total tumor volume and lesional intensity
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Assessment method [2]
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By direct comparison of sites of known metastatic disease between 68Ga NeoB and conventional imaging. Assessing the presence and/or absence of lesions using SUVmax/SUVmean)
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Comparison of variation in total tumour volume
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Assessment method [3]
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To compare total tumour volume of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.
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Timepoint [3]
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2 years
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Eligibility
Key inclusion criteria
- Female patients aged 18 or above
- Ability to provide informed consent documentation indicating that they understand the
purpose of and procedures required for the study, and are willing to participate in
the study
- Estrogen/Progesterone receptor +ve HER2 negative disease confirmed on prior biopsy
(primary or metastatic site).
- Metastatic breast cancer being staged or re-staged prior to treatment of metastatic
disease (including those presenting with up-front metastatic disease with primary
breast cancer in-situ and those who have progressed on a line of treatment for
metastatic breast cancer that are suitable for another line of treatment)
- Metastatic breast cancer being staged or restaged prior to change in treatment with
standard imaging within 3 weeks of enrolment (CT CAP, bone scan, FDG PET CT)
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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
- Pregnancy or lactation (patients should use highly effective methods of contraception
during and for 12h after administration)
- Significant inter-current acute illness as per investigator discretion that prevent
undertaking study procedures
- History of current active malignancy as per investigator discretion other than breast
cancer.
- Known or expected hypersensitivity to 68Ga NeoB
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/02/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment postcode(s) [1]
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2010 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
St Vincent's Hospital, Sydney
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Novartis
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase IIb pilot study will enrol 20 patients (women) presenting with metastatic breast
cancer (ER/PR + HER2- on histology) who require imaging for staging or re-staging of their
disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05889728
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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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Louise Emmett, MD
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Address
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St Vincent's Hospital, Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Louise Emmett, MD
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Address
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Country
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Phone
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+61 2 8382 1819
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05889728
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