The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging
NCT06359054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2024-04-11
Summary
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
Interventions
- DIAGNOSTIC_TEST
-
18F FDG PET/CT
18F-FDG PET/CT Imaging: Preparation: Participants will be instructed to fast for at least 6 hours before the procedure to ensure low insulin levels and high FDG uptake by cancer cells. Radiopharmaceutical Administration: Each participant will receive an intravenous injection of 18F-FDG, dosed at approximately 5.2 MBq/kg (0.14 mCi/kg) of body weight. Imaging Protocol: After the injection, participants will rest in a quiet and dimly lit room for approximately 60 minutes to allow for optimal distribution and uptake of 18F-FDG by the tissues. Subsequently, they will be positioned on the PET/CT scanner bed, and imaging will be performed from the vertex to the proximal thighs. The scan will include a low-dose CT for attenuation correction followed by PET imaging, with the acquisition time adjusted based on the specific protocol (typically 2-3 minutes per bed position).
- DIAGNOSTIC_TEST
-
68Ga DOTATATE PET/CT
68Ga-DOTATATE PET/CT Imaging: Preparation: No specific fasting is required for 68Ga-DOTATATE PET/CT. However, participants may be advised to hydrate well before the procedure. Radiopharmaceutical Administration: Participants will receive an intravenous injection of 68Ga-DOTATATE, dosed at approximately 2.2 MBq/kg (0.06 mCi/kg) of body weight. Imaging Protocol: Similar to the 18F-FDG protocol, after receiving 68Ga-DOTATATE, participants will wait for about 60 minutes to allow for sufficient uptake of the tracer. They will then undergo PET/CT scanning in a supine position, covering the same body regions as the FDG scan. A low-dose CT scan will be conducted first for attenuation correction, followed by the PET scan, with acquisition parameters tailored to the optimal detection of somatostatin receptor expression.
Sponsors & Collaborators
-
Celal Bayar University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-11
- Primary Completion
- 2023-05-15
- Completion
- 2023-09-15
Countries
- Turkey (Türkiye)
Study Locations
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