Somatostatin receptor (SSTR) imaging with 68Ga-DOTATATE PET/CT and its comparison with 18F-FDG PET/CT in patients with estrogen receptor positive (ER positive) metastatic breast cancer (mBC)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 68Ga-DOTATATE PET/CT imaging
Study Overview
Brief Summary
Breast cancer is the most commonly diagnosed malignancy worldwide and is the leading cause of cancer-related mortality in women. Hormone receptor status is an important biomarker in breast cancer influencing management strategy. Majority (~70-75%) of breast cancers are reported to be ER+. The mortality of breast cancer correlates with disease extent. The presence of distant metastases is associated with poor survival outcomes. The median five-year survival rate in ER+ mBC is less than 30%, suggesting the need for newer diagnostic and therapeutic techniques to improve patient outcomes in this population.
Identification of specific tumor-associated antigens and receptors has led to a paradigm shift in the fields of molecular imaging and targeted cancer therapy. Immunohistochemistry studies have reported SSTR expression in breast cancer tissue samples with higher rates of expression in ER+ breast cancer. There is a dearth of published literature evaluating the role of SSTR-targeted PET imaging in ER+ breast cancer patients. This phase II trial will determine if SSTR-targeted imaging with 68Ga-DOTATATE PET/CT can visualize malignancy in patients with ER+ mBC. The results of this study will also guide the feasibility of SSTR-targeted radionuclide therapy in progressive ER+ mBC patients having limited therapeutic options.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Biopsy proven estrogen receptor positive metastatic breast cancer
- •Patients who have undergone 18F-FDG PET/CT for staging/re-staging within the last 3 weeks
- •At least one site of known active disease on imaging within 3 months
- •If a woman is of childbearing potential, a negative urine pregnancy test before administration of SSTR-targeted PET radiotracer would be mandatory.
Exclusion Criteria
- •Pregnant and lactating females
- •Patients who refuse to give written informed consent
- •Unable to give informed consent or withdrawal of consent any point of time
- •Recent anti-cancer chemotherapy/surgery in less than four weeks or radiotherapy in less than eight weeks
- •Use of long-acting SSTR-targeting agents (example: lanreotide) within 28 days of SSTR-targeted imaging
- •Use of short-acting SSTR-targeting agents (example: sandostatin) within 24 hours of SSTR-targeted imaging
- •Concurrent primary malignancy other than known metastatic breast cancer, 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
- •Subjects with allergy/hypersensitivity to SSTR-targeted imaging agents
- •Current use of high-dose glucocorticoids (≥ 20 mg prednisone per day or equivalent) 10.
Outcomes
Primary Outcomes
68Ga-DOTATATE PET/CT imaging
Time Frame: 45 minutes to 1 hour from time of injection
(Assessment of 68Ga-DOTATATE PET/CT imaging to detect lesions in patients with estrogen receptor positive metastatic breast cancer)
Time Frame: 45 minutes to 1 hour from time of injection
Secondary Outcomes
No secondary outcomes reported