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

• Status: Recruiting
• Trial end date: 2025-02-23
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Vincent's Hospital, Sydney
• Collaborator: Novartis

Criteria

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