Breast Cancer Clinical Trial
Official 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
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | February 23, 2025 |
Est. primary completion date | February 20, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | St Vincent's Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
St Vincent's Hospital, Sydney | Novartis |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images) | 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 | Comparison of SUVmax/mean | 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 | |
Secondary | Quantitative Variation in Lesion measuring total tumor volume and lesional intensity | 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 | |
Secondary | Comparison of variation in total tumour volume | 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 |
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