Clinical trial · Interventional
The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging
The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging; a Prospective Study Compared With 18F FDG PET/CT
- 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)
Currently, F-18 FDG PET/CT is routinely used for breast cancer staging and treatment response assessment. Most breast cancers express Estrogen Receptor (ER) and Progesterone Receptor (PR) and this subtype shows lower activity on FDG imaging. 68Ga DOTATATE PET/CT is an effective imaging option for somatostatin receptor (SSTR) positive neuroendocrine tumors. There are case reports showing 68Ga DOTATATE uptake in non-Hodgkin lymphoma, meningioma, breast cancer, thyroid adenoma and papillary carcinoma. There are also histochemical studies showing that SSTR is a potential radiopharmaceutical target for ER+/PR+ breast cancer . Its hypothesized that 68Ga DOTATATE PET/CT may be superior to 18F FDG PET/CT primarily in hormone receptor (HR) positive breast cancer. In this study, its aimed to compare the uptake pattern of breast cancer lesions and HR status with 68Ga DOTATATE and 18F FDG uptake in lesions.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
| 68Ga DOTATATE PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Cancer Patient
- interventionNames
- Diagnostic Test: 18F FDG PET/CT
- Diagnostic Test: 68Ga DOTATATE PET/CT
Primary outcomes (1)
- measure
- Comparative Diagnostic Accuracy of 68Ga DOTATATE and 18F FDG PET/CT
- timeFrame
- The diagnostic accuracy will be assessed immediately following the completion of both PET/CT scans, with each participant undergoing both scans within a one-week interval. The analysis of images and interpretation of results will occur after all particip
- description
- The primary outcome of this study is to assess and compare the diagnostic accuracy of 18F-FDG PET/CT and 68Ga-DOTATATE PET/CT in detecting primary and metastatic breast cancer lesions. This will be evaluated through the identification of lesion uptake patterns, quantified by the maximum standardized uptake value (SUVmax), and the presence of extra-axillary lymph node and distant metastases as indicated by each imaging modality.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 to 90 years old * Performance status: Karnofsky score 70 or better or WHO performance status 2 or better * Pathologically proven breast cancer by biopsy * Patients must be able to understand the meaning of the study and sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff Exclusion Criteria: * Any medical or psychiatric condition that compromises the subject´s ability to participate in the study * Any other significant disease including liver or renal disease * Pregnant or lactating women
References
Publications (1)
- BACKGROUNDGuirguis MS, Adrada BE, Surasi DS, Dryden MJ. 68Ga-DOTATATE Uptake in Primary Breast Cancer. Clin Nucl Med. 2021 Mar 1;46(3):248-249. doi: 10.1097/RLU.0000000000003421. PMID 33234932