| CTRI Number |
CTRI/2026/02/103534 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study using a PET/CT scan and targeted radiation therapy using Fibroblast activated protein inhibitor for patients in metastatic soft tissue sarcoma |
|
Scientific Title of Study
|
To evaluate FAPI as a potential theranostic in soft tissue sarcoma using 68Ga-FAPI-46 PET/CT and 177Lu-FAPI 46 therapy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogita Khandelwal |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Nuclear Medicine, AIIMS New Delhi
Department of Nuclear Medicine, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9414055993 |
| Fax |
|
| Email |
ykyogita28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shamim A Shamim |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Nuclear Medicine, AIIMS New Delhi
Department of Nuclear Medicine, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9868350491 |
| Fax |
|
| Email |
sashamim2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogita Khandelwal |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Nuclear Medicine, AIIMS New Delhi
Department of Nuclear Medicine, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9414055993 |
| Fax |
|
| Email |
ykyogita28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institue of Medical Sciences, New Delhi |
| Address |
Department of Nuclear Medicine, AIIMS, New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yogita Khandelwal |
AIIMS New Delhi |
Department of Nuclear Medicine, AIIMS New Delhi - 110029
South
DELHI |
9414055993
ykyogita28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C49||Malignant neoplasm of other connective and soft tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
1. At Baseline
2. Throughout study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the efficacy of 177Lu-FAPI-2286 therapy using clinical parameters and PERCIST. |
Throughout study period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ykyogita28@gmail.com].
- For how long will this data be available start date provided 02-01-2026 and end date provided 01-12-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective, single arm, open label interventional theranostic study evaluating fibroblast activation protein inhibitor based imaging and radionuclide therapy in patients with metastatic soft tissue sarcoma who have exhausted standard treatment options. |