Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed metastatic ovarian adenocarcinoma at baseline who have now exhausted all conventional therapeutic options. Life expectancy greater than 12 weeks. Patients with metastatic ovarian adenocarcinoma who have progressed on 3 lines of chemotherapy. For [177Lu]Lu FAPI 46/FAP 2286 therapy, adequate end organ function as given by: Hemoglobin more than or equal to 10g/dl. Leucocytes more than or equal to 3000/mcL Platelets more than or equal to 75,000/mcL Total Bilirubin less than or equal to 3 x upper limit AST/ALT/ALP less than or equal to 3 x upper limit INR less than or equal to 1.5 x upper limit S. Creatinine less than or equal to 1.7 mg/dl
Exclusion criteria
Exclusion criteria: Eastern Cooperative Oncology Group [ performance status 2. Pregnant or lactating women. Refusal to give written informed consent or withdrawal of consent at any point of time. Recent anti cancer chemotherapy/surgery in less than four weeks or radiotherapy in less than 8 weeks. Active/acute serious illness/infection uncontrolled by oral medications. Concurrent primary malignancy other than ovarian adenocarcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the diagnostic performance of [68 Ga]Ga FAPI 46/FAP 2286 PET/CT in comparison to [18 F]FDG PET/CT in metastatic ovarian adenocarcinoma patients. Timepoint: 0-12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the feasibility and safety of the [177 Lu]Lu FAPI (FAPI-46/FAP-2286) therapy in patients with metastatic ovarian adenocarcinoma. To assess the efficacy of [177 Lu] Lu FAPI 46/FAP 2286 therapy using clinical parameters and PERCIST. To assess the quality of life and determine progression free survival after 177 [Lu]Lu FAPI 46/FAP 2286.Timepoint: 12-24 months | — |
Countries
India
Contacts
All India Institute of Medical Sciences