Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Drug - 68Ga-DOTATATE: 68Ga-DOTATATE will be injected intravenously at a dose of approximately 111 MBq, around 60 minutes before PET/CT scan acquisition.
Control Intervention1: NIL: NIL
Sponsors
All India Institute of Medical Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Biopsy proven estrogen receptor positive metastatic breast cancer 2. Patients who have undergone 18F-FDG PET/CT for staging/re-staging within the last 3 weeks 3. At least one site of known active disease on imaging within 3 months 4. If a woman is of childbearing potential, a negative urine pregnancy test before administration of SSTR-targeted PET radiotracer would be mandatory.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating females 2. Patients who refuse to give written informed consent 3. Unable to give informed consent or withdrawal of consent any point of time 4. Recent anti-cancer chemotherapy/surgery in less than four weeks or radiotherapy in less than eight weeks 5. Use of long-acting SSTR-targeting agents (example: lanreotide) within 28 days of SSTR-targeted imaging 6. Use of short-acting SSTR-targeting agents (example: sandostatin) within 24 hours of SSTR-targeted imaging 7. 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 8. Subjects with allergy/hypersensitivity to SSTR-targeted imaging agents 9. Current use of high-dose glucocorticoids (>= 20 mg prednisone per day or equivalent) 10. Active serious infection not controlled by antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 68Ga-DOTATATE PET/CT imaging (Assessment of 68Ga-DOTATATE PET/CT imaging to detect lesions in patients with estrogen receptor positive metastatic breast cancer)Timepoint: 45 minutes to 1 hour from time of injection | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactKunal Ramesh Chandekar
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed