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

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

[68Ga]GA-NeoB

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

St Vincent's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of SUVmax/mean

To compare SUV max/mean of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.

Quantitative Variation in Lesion measuring total tumor volume and lesional intensity

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)

Comparison of variation in total tumour volume

To compare total tumour volume of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.

Full Information

NCT ID

NCT05889728

First Posted

April 5, 2023

Last Updated

May 22, 2023

Sponsor

St Vincent's Hospital, Sydney

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT05889728

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 20, 2023 (Actual)

Primary Completion Date

February 20, 2025 (Anticipated)

Study Completion Date

February 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St Vincent's Hospital, Sydney

Collaborators

Novartis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

[68Ga]GA-NeoB

Intervention 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).

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Comparison of SUVmax/mean

Description

To compare SUV max/mean of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.

Time Frame

2 years

Title

Quantitative Variation in Lesion measuring total tumor volume and lesional intensity

Description

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)

Time Frame

2 years

Title

Comparison of variation in total tumour volume

Description

To compare total tumour volume of 68Ga- NeoB imaging to 18F-FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer.

Time Frame

2 years

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

women with ER/PR+ HER2 - metastatic breast cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Louise Emmett, MD

Phone

+61 2 8382 1819

Email

emmetthruby@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Shikha Agrawal, MPH

Phone

+61 2 8382 1819

Email

shikha.agrawal@svha.org.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louise Emmett, MD

Organizational Affiliation

St Vincent's Hospital, Sydney

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Vincent's Hospital

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louise Emmett, MD

Phone

+61 2 8382 1819

Email

emmetthruby@gmail.com

First Name & Middle Initial & Last Name & Degree

Shikha Agrawal, MPH

Phone

+61 2 8382 1819

Email

shikha.agrawal@svha.org.au

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing 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.

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial