Clinical trial · Interventional
Study of Dotatate Imaging in Breast Cancer
Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
NCT05880394CI-TRIAL-00073911unknownPhase 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 will be a Phase 2 clinical trial to assess somatostatin receptor (SSTR) expression in Stage IV estrogen receptor positive (ER+) breast cancer using Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT.
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 Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Copper-64 DOTATATE | Drug | — | UNRESOLVED |
| Gallium-68 DOTATATE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV)
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age of at least 18 years at the time of signing the informed consent. * Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging. * For women of childbearing potential (WOCBP): a. Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (≥ 12 continuous months of amenorrhea \[no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.\] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug). * Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence. Exclusion Criteria: * Known hypersensitivity to Gallium-68 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 DOTATATE * Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours. * Unable to perform PET/CT scans according to technical specifications and local guidelines. * Concurrent primary malignancy, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study. * Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. * Unable or unwilling to comply with the requirements of the study protocol. * Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.
References
Publications (0)
Data not yet available
No reference posted for this study.