- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05889728
Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer
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
Study Overview
Detailed Description
There is little published literature evaluating the usefulness of Ga Bombesin-PET imaging in comparison to currently accepted imaging modalities for detecting progressive metastatic breast cancer. This study aims to produce preliminary research to evaluate its clinical value in breast cancer, given the promising previously published cell line and mouse work in ER/PR+ HER2- tumours. It further aims to ascertain the theranostic potential of the NeoB peptide in the ER/PR + Her 2- population, particularly assessing the level of heterogeneity at sites of active malignancy compared to FDG PET.
This study will add PET CT imaging using a tracer agent (NeoB) that directly targets the breast cancer cell. The ability of this new PET CT scan to detect sites of metastatic disease will be compared to standard procedures which include Diagnostic CT, bone scan and 18F-FDG PET.
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).
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Louise Emmett, MD
- Phone Number: +61 2 8382 1819
- Email: emmetthruby@gmail.com
Study Contact Backup
- Name: Shikha Agrawal, MPH
- Phone Number: +61 2 8382 1819
- Email: shikha.agrawal@svha.org.au
Study Locations
-
-
New South Wales
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Sydney, New South Wales, Australia, 2010
- Recruiting
- St Vincent's hospital
-
Contact:
- Louise Emmett, MD
- Phone Number: +61 2 8382 1819
- Email: emmetthruby@gmail.com
-
Contact:
- Shikha Agrawal, MPH
- Phone Number: +61 2 8382 1819
- Email: shikha.agrawal@svha.org.au
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)
Time Frame: 2 years
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of SUVmax/mean
Time Frame: 2 years
|
To compare SUV max/mean of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.
|
2 years
|
Quantitative Variation in Lesion measuring total tumor volume and lesional intensity
Time Frame: 2 years
|
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)
|
2 years
|
Comparison of variation in total tumour volume
Time Frame: 2 years
|
To compare total tumour volume of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Louise Emmett, MD, St Vincent's Hospital, Sydney
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Best TRial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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