A clinical study using a PET/CT scan and targeted radiation therapy using Fibroblast activated protein inhibitor for patients in metastatic soft tissue sarcoma

To evaluate FAPI as a potential theranostic in soft tissue sarcoma using 68Ga-FAPI-46 PET/CT and 177Lu-FAPI 46 therapy. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103534

Enrollment

Registered

2026-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C49- Malignant neoplasm of other connective and soft tissue

Interventions

Intervention1: 68Ga-FAPI PET/CT 177Lu FAPI 2286 therapy: Patient with metastatic soft tissue sarcoma undergo 68Ga-FAPI PET/CT, selected patient will undergo 3-6 cycles of 177Lu FAPI 2286 therapy Cont

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or above and providing written consent. 2. Histological confirmation of soft tissue sarcoma. 3. Metastatic disease 4. Life expectancy greater than 12 weeks 5. For 177Lu-FAPI-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 and S.Creatinine less than or equal 1.7 mg/dl

Exclusion criteria

Exclusion criteria: 1. Eastern Cooperative Oncology Group [ECOG] performance status more than 3. 2. Pregnant or lactating women. 3. Refusal to give written informed consent or withdrawal of consent at any point of time. 4. Recent anti-cancer chemotherapy/surgery in less than four weeks or radiotherapy less than 8 weeks. 5. Active/acute serious illness/infection uncontrolled by oral medications. 6. Concurrent primary malignancy other than soft tissue sarcoma.

Design outcomes

Primary

Measure	Time frame
1.To evaluate the role of 68Ga-FAPI-46 PET/CT in metastatic soft tissue sarcoma patients. 2.To evaluate the feasibility and safety of the 177Lu-FAPI-2286 therapy in metastatic soft tissue sarcoma patients. Timepoint: 1.At Baseline 2.Throughout study period	—

Secondary

Measure	Time frame
1. To assess the efficacy of 177Lu-FAPI-2286 therapy using clinical parameters and PERCIST.Timepoint: Throughout study period	—

Countries

India

Contacts

Public ContactYogita Khandelwal

AIIMS, New Delhi

sashamim2002@gmail.com9868350491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026