Clinical trial NCT05889728: Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: St Vincent's Hospital, Sydney
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2023-06-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Female patients aged 18 or above with ER/PR+ HER2 - metastatic breast cancer presenting for standard of care staging/restaging prior to treatment of metastatic disease.
Primary purpose: DIAGNOSTIC

Brief 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.

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).

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

Primary outcomes:
measure: Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of SUVmax/mean
timeFrame: 2 years
measure: Quantitative Variation in Lesion measuring total tumor volume and lesional intensity
timeFrame: 2 years
measure: Comparison of variation in total tumour volume
timeFrame: 2 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
Study officials:
affiliation: St Vincent's Hospital, Sydney
name: Louise Emmett, MD
role: PRINCIPAL_INVESTIGATOR
References: