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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
Not applicable
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
Trial website
Trial related presentations / publications
Public notes

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
emmetthruby@gmail.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05889728