Clinical trial · Interventional
68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Sarcoma: An Exploratory Biodistribution Study With Histopathology Validation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
This early phase I trial studies an imaging technique called 68Ga-FAPi-46 PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with sarcoma. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi. Because some cancers take up 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Radiation | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Gallium Ga 68 FAPi-46 | Drug | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (68Ga-FAPI-46 PET/CT)
- description
- Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
- interventionNames
- Procedure: Computed Tomography
- Drug: Gallium Ga 68 FAPi-46
- Procedure: Positron Emission Tomography
- Radiation: 18F-FDG
Primary outcomes (1)
- measure
- Biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues
- timeFrame
- At 20-90 minutes after injection
- description
- Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are scheduled to undergo surgical excision or biopsy of a suspected sarcoma primary, or a suspected recurrent or metastatic lesion. * Patients who are ≥ 18 years old at the time of the radiotracer administration. * Patients who can provide written informed consent. * Patients who are able to remain still for duration of imaging procedures (up to one hour for each). Exclusion Criteria: * Patient is pregnant or nursing. * Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT * Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data.
References
Publications (0)
Data not yet available