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Trial Title:
Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer
NCT ID:
NCT05889728
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]GA-NeoB
Description:
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).
Arm group label:
68Ga Bombesin PET/CT (NeoB) imaging for staging breast cancer
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).
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
women with ER/PR+ HER2 - metastatic breast cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St Vincent's Hospital
Address:
City:
Sydney
Zip:
2010
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Louise Emmett, MD
Phone:
+61 2 8382 1819
Email:
emmetthruby@gmail.com
Contact backup:
Last name:
Shikha Agrawal, MPH
Phone:
+61 2 8382 1819
Email:
shikha.agrawal@svha.org.au
Start date:
February 20, 2023
Completion date:
February 23, 2025
Lead sponsor:
Agency:
St Vincent's Hospital, Sydney
Agency class:
Other
Collaborator:
Agency:
Novartis
Agency class:
Industry
Source:
St Vincent's Hospital, Sydney
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889728
