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

NCT05889728 | Unknown Phase 2 FDA Drug

• 1 other identifier: Best TRial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)

  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 Outcomes (3)

• Comparison of SUVmax/mean

  2 years

• Quantitative Variation in Lesion measuring total tumor volume and lesional intensity

  2 years

• Comparison of variation in total tumour volume

  2 years

Study Arms (1)

68Ga Bombesin PET/CT (NeoB) imaging for staging breast cancer

EXPERIMENTAL

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).

Drug: [68Ga]GA-NeoB

Interventions

[68Ga]GA-NeoB DRUG

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).

68Ga Bombesin PET/CT (NeoB) imaging for staging breast cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women with ER/PR+ HER2 - metastatic breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead
• Novartis: collaborator

Study Sites (1)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Louise Emmett, MD

  St Vincent's Hospital, Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Emmett, MD

CONTACT

+61 2 8382 1819; emmetthruby@gmail.com

Shikha Agrawal, MPH

CONTACT

+61 2 8382 1819; shikha.agrawal@svha.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: June 5, 2023
• Study Start: February 20, 2023
• Primary Completion: February 20, 2025
• Study Completion: February 23, 2025
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)