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

May 22, 2023 updated by: Louise Emmett, St Vincent's Hospital, Sydney

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • New South Wales
      • Sydney, New South Wales, Australia, 2010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga Bombesin PET/CT (NeoB) imaging for staging breast cancer
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 or up to a maximum of 250 Mbq).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of SUVmax/mean
Time Frame: 2 years
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
Quantitative Variation in Lesion measuring total tumor volume and lesional intensity
Time Frame: 2 years
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
Comparison of variation in total tumour volume
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Louise Emmett, MD, St Vincent's Hospital, Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

February 20, 2025

Study Completion (Estimated)

February 23, 2025

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Best TRial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results from both the 68NeoB PET CT and conventional imaging will be provided to the referring physician. It will be made clear to the physician that the 68NeoB PET results are experimental prior to participant enrolment. While the findings of the experimental agent are conveyed to the treating clinician, it is made clear that the results are experimental and should not be used for clinical purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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