Clinical trial · Interventional
Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer
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
NCT05889728CI-TRIAL-00122788completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]GA-NeoB | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga Bombesin PET/CT (NeoB) imaging for staging breast cancer
- 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).
- interventionNames
- Drug: [68Ga]GA-NeoB
Primary outcomes (1)
- measure
- Assessment of Diagnostic Accuracy using a standard of truth (Biopsy, response to treatment RECIST and correlate images)
- timeFrame
- 2 years
- 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
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSabahi 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. PMID 40147847