Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05889728




Registration number
NCT05889728
Ethics application status
Date submitted
5/04/2023
Date registered
5/06/2023
Date last updated
5/06/2023

Titles & IDs
Public title
Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer
Scientific 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
Secondary ID [1] 0 0
Best TRial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - [68Ga]GA-NeoB

Active comparator: Active Intervention - The intervention comprises vegetable burger containing high nitrate vegetables (100g of spinach, \~1000mg/kg FW nitrate) on white bread sandwich, provided at breakfast and lunch.

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).


Treatment: Drugs: [68Ga]GA-NeoB
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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)
Timepoint [1] 0 0
2 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/02/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05889728
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Louise Emmett, MD
Address 0 0
St Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Louise Emmett, MD
Address 0 0
Country 0 0
Phone 0 0
+61 2 8382 1819
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05889728