Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889728
• Other study ID #: Best TRial
• Status: Recruiting
• Phase: Phase 2
• Start date: February 20, 2023
• Est. completion date: February 23, 2025

Study information

• Verified date: May 2023
• Source: St Vincent's Hospital, Sydney
• Contact: Louise Emmett, MD
• Phone: +61 2 8382 1819
• Email: emmetthruby[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• [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).

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
St Vincent's Hospital, Sydney	Novartis

Country where clinical trial is conducted

Australia, 

Outcome

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