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Trial registered on ANZCTR
Registration number
ACTRN12624001122549
Ethics application status
Approved
Date submitted
3/09/2024
Date registered
18/09/2024
Date last updated
18/09/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of Fibroblast Activation Protein Inhibitor Positron Emission Tomography / Computed Tomography in staging and management of locally advanced lobular breast cancer: LUMINA Study
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Scientific title
Impact of FAPI PET/CT on staging and management of locally advanced lobular breast cancer (LUMINA)
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Secondary ID [1]
312878
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NIL Known
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Universal Trial Number (UTN)
U1111-1313-1787
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Trial acronym
LUMINA Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Locally advanced lobular breast cancer
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Condition category
Condition code
Cancer
331536
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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
Intervention Name: [68Ga] (Gallium)]-Fibroblast activation Protein inhibitor (FAPI)-04 PET/CT Imaging Procedure
Short Intervention name: [68Ga]Ga-FAPI-04 PET/CT (FAPI PET/CT). A weight based dose of [68Ga]Ga-FAPI-04 tracer dose will be injected intravenously. After a 30 minute resting (uptake) time the patient will be scanned on a digital PET/CT scanner (United Imaging uMI 780), Total scan time will be approximately 15 - 20 minutes (depending on patient height). Total appointment time for the scan including preparation before the scan will be 90 minutes.
A Data Safety and Monitoring Committee (DSMC) has been established, comprising of 2 external Oncologists, independent Biostatistician and Mercy Molecular Imaging and Therapy Operations manager (who is not directly involved in study). DSMC will be responsible for monitoring of adherence to the intervention. A 6 monthly report will be provided to DSMC.
A Single intervention of FAPI PET/CT Imaging will be performed onsite for each trial participant and delivered by qualified members of our research team, including Nuclear Medicine Imaging Technicians and Radio Pharmacist, Radiologist, Research Nurse.
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Intervention code [1]
329416
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary study endpoint is the proportion of participants with AJCC Stage 2B to 3C breast cancer who have a change in disease stage following FAPI PET/CT.
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Assessment method [1]
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Questionnaire designed specifically for LUMINA will be provided to referring clinicians Questionnaires pre and post FAPI PET CT Imaging. The questionnaire will require clinicians to specify proposed management pre scan and change in management (if any) post scan.
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Timepoint [1]
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Pre Imaging Visit 1 (-28 days) and Post imaging Visit 1.
Endpoints assessment for the study (stage and management change) will be assessed at the conclusion of the study at n = 50.
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Secondary outcome [1]
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The secondary endpoint is the proportion of participants who the clinician recommends a change in clinical management of their disease following FAPI PET/CT.
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Assessment method [1]
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Questionnaire designed specifically for LUMINA will be provided to referring clinicians Questionnaires pre and post FAPI PET CT Imaging. The questionnaire will require clinicians to specify proposed management pre scan and change in management (if any) post scan.
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Timepoint [1]
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Pre Imaging Visit 1 (-28 days) and Post Imaging Visit 1
Endpoints assessment for the study (stage and management change) will be assessed at the conclusion of the study at n = 50.
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Eligibility
Key inclusion criteria
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Histologically proven invasive lobular breast cancer with stage 2B to 3C based on conventional pathological and radiological staging currently available in New Zealand and based on local practice.
2. Participant must be 18 years of age and over, at the time of signing the informed consent.
3. Participants must be able to give consent to the study and understand the study information.
4. Participants who have newly diagnosed ILC without known distant metastatic disease on
conventional imaging.
5. Capable of giving signed informed consent as described including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1. Participants with a history of other known malignancy
2. Impaired renal function of eGFR <30
3. Unable to give consent
4. Known hypersensitivity to CT contrast (Omnipaque)
5. Participants who return a positive pregnancy test at Day 0.
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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
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
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/10/2024
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Actual
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Date of last participant enrolment
Anticipated
20/10/2026
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Actual
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Date of last data collection
Anticipated
20/10/2027
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Grant funded by Breast Cancer Foundation NZ- Partnering for Innovation in Equitable Breast Cancer Care
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Address [1]
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Country [1]
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New Zealand
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Primary sponsor type
Other
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Name
Mercy Radiology, Epsom, Auckland
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319603
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Country [1]
319603
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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19/07/2024
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Approval date [1]
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15/08/2024
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Ethics approval number [1]
316049
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2024 FULL 20393
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Summary
Brief summary
This study aims to evaluate the impact of a novel positron emission tomography tracer, called Gallium 68-Fibroblast Activation Protein Inhibitor-04 Positron Emission Tomography/ Computed Tomography ( [68Ga]Ga-FAPI-04 PET/CT or FAPI PET/CT) on initial staging of breast cancer patients. Who is it for? You may be eligible for this study if you are an adult patient who has been diagnosed with locally advanced and/or node positive, high risk (stage 2B to 3C) Invasive Lobular Breast cancer (ILC). Study details Participants will receive an injection of a radioactive tracer agent (FAPI-04) before undergoing 15-20 minute PET/CT scan. Participants and their treating clinicians will be followed up for information on their disease stage and clinical management over 12 months post-scan. It is hoped that findings from this study help doctors and researchers understand the clinical utility and impact of FAPI PET/CT in the staging and management of Invasive Lobular Breast Cancer.
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Trial website
N/A
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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 Remy Lim
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Address
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Mercy Radiology, 100 Mountain Road, Epsom, Auckland 1023
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Country
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New Zealand
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Phone
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+64 09 6303324
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Remy Lim
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Address
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Mercy Radiology, 100 Mountain Road, Epsom, Auckland 1023
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Country
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New Zealand
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Phone
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+64 09 6303324
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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
Name
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Remy Lim
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Address
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Mercy Radiology, 100 Mountain Road, Epsom, Auckland 1023
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Country
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New Zealand
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Phone
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+64 09 6303324
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Fax
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Email
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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)?
No
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No/undecided IPD sharing reason/comment
No - IPD will not be available
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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