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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
Scientific title
Impact of FAPI PET/CT on staging and management of locally advanced lobular breast cancer (LUMINA)
Secondary ID [1] 312878 0
NIL Known
Universal Trial Number (UTN)
U1111-1313-1787
Trial acronym
LUMINA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced lobular breast cancer 335029 0
Condition category
Condition code
Cancer 331536 331536 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329416 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339283 0
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.
Timepoint [1] 339283 0

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.
Secondary outcome [1] 439363 0
The secondary endpoint is the proportion of participants who the clinician recommends a change in clinical management of their disease following FAPI PET/CT.
Timepoint [1] 439363 0
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.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/10/2024
Actual
Date of last participant enrolment
Anticipated
20/10/2026
Actual
Date of last data collection
Anticipated
20/10/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 26538 0
New Zealand
State/province [1] 26538 0
Auckland

Funding & Sponsors
Funding source category [1] 317318 0
Charities/Societies/Foundations
Name [1] 317318 0
Grant funded by Breast Cancer Foundation NZ- Partnering for Innovation in Equitable Breast Cancer Care
Country [1] 317318 0
New Zealand
Primary sponsor type
Other
Name
Mercy Radiology, Epsom, Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 319603 0
None
Name [1] 319603 0
Address [1] 319603 0
Country [1] 319603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316049 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 316049 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 316049 0
New Zealand
Date submitted for ethics approval [1] 316049 0
19/07/2024
Approval date [1] 316049 0
15/08/2024
Ethics approval number [1] 316049 0
2024 FULL 20393

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.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136614 0
Dr Remy Lim
Address 136614 0
Mercy Radiology, 100 Mountain Road, Epsom, Auckland 1023
Country 136614 0
New Zealand
Phone 136614 0
+64 09 6303324
Fax 136614 0
Email 136614 0
[email protected]
Contact person for public queries
Name 136615 0
Dr Remy Lim
Address 136615 0
Mercy Radiology, 100 Mountain Road, Epsom, Auckland 1023
Country 136615 0
New Zealand
Phone 136615 0
+64 09 6303324
Fax 136615 0
Email 136615 0
[email protected]
Contact person for scientific queries
Name 136616 0
Remy Lim
Address 136616 0
Mercy Radiology, 100 Mountain Road, Epsom, Auckland 1023
Country 136616 0
New Zealand
Phone 136616 0
+64 09 6303324
Fax 136616 0
Email 136616 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be available


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.