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

CompletedPhase 2

Sponsor: St Vincent's Hospital, Sydney

Conditions: Breast Cancer

Interventions: [68Ga]GA-NeoB

Countries: Australia

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Sydney, New South Wales, Australia