Breast CancerPhase 2NCT05889728
Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer
A Phase 2 study testing [68Ga]GA-NeoB in people with Breast Cancer, run by St Vincent's Hospital, Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- [68Ga]GA-NeoB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Feb 2023to 23 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Breast Cancer
- Being tested
- [68Ga]GA-NeoB
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]GA-NeoBDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: [68Ga]GA-NeoB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
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)
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start20 Feb 2023
- Primary completion20 Feb 2025
- Study completion23 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital, Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Louise Emmett, St Vincent's Hospital, Sydney
- Investigators
- Louise Emmett, MD, Principal investigator, St Vincent's Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889728
- Sponsor's protocol ID
- Best TRial
- Status last verified
- Aug 2026
- First submitted
- 5 Apr 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Sabahi Z, Nguyen A, Wong K, Li S, Papa N, Lim E, Dear RF, Menzies AM, Boyle F, Antill Y, Kiely BE, Forster BC, Mak C, Adams D, Pugliano L, Spillane A, Sharma S, Hickey A, Poole A, Agrawal S, Khan S, Ayati N, Emmett L. Diagnostic Potential of 68Ga-NeoB PET/CT with Estrogen Receptor- and Progesterone Receptor-Positive Breast Cancer Undergoing Staging or Restaging for Metastatic Disease. J Nucl Med. 2025 May 1;66(5):700-706. doi: 10.2967/jnumed.124.268896.
PubMed 40147847
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05889728
- Acronym / sponsor ID
- Best TRial
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St Vincent's Hospital, SydneyUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 23 Feb 2025 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 68Ga Bombesin PET/CT (NeoB) imaging for staging breast cancer | Experimental | Drug: [68Ga]GA-NeoBAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]GA-NeoBIs 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). | Drug | 68Ga Bombesin PET/CT (NeoB) imaging for staging breast cancer |
Primary outcome
Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)
Time frame: 2 years
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
3 secondary outcomes
Comparison of SUVmax/mean
Time frame: 2 years
Quantitative Variation in Lesion measuring total tumor volume and lesional intensity
Time frame: 2 years
Comparison of variation in total tumour volume
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 40147847Sabahi Z, Nguyen A, Wong K, Li S, Papa N, Lim E, Dear RF, Menzies AM, Boyle F, Antill Y, Kiely BE, Forster BC, Mak C, Adams D, Pugliano L, Spillane A, Sharma S, Hickey A, Poole A, Agrawal S, Khan S, Ayati N, Emmett L. Diagnostic Potential of 68Ga-NeoB PET/CT with Estrogen Receptor- and Progesterone Receptor-Positive Breast Cancer Undergoing Staging or Restaging for Metastatic Disease. J Nucl Med. 2025 May 1;66(5):700-706. doi: 10.2967/jnumed.124.268896.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Emmett, MD principal investigator
St Vincent's Hospital, Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]GA-NeoB in people with Breast Cancer, run by St Vincent's Hospital, Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05889728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.