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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Cancer 0 0 0 0
Breast

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

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
Secondary outcome [1] 0 0
Comparison of SUVmax/mean
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Quantitative Variation in Lesion measuring total tumor volume and lesional intensity
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Comparison of variation in total tumour volume
Timepoint [3] 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
N/A
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)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis
Address [1] 0 0
Country [1] 0 0

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/ct2/show/NCT05889728
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05889728