Clinical trial · Interventional
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
PET Imaging Study of 68Ga-FAPI-46 Biodistribution in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. 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-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.
Conditions
Conditions (34)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Carcinoma | Anal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Carcinoma | Gastric Carcinoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Fludeoxyglucose F-18 | Other | — | UNRESOLVED |
| Gallium Ga 68 FAPi-46 | Radiation | — | 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 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
- interventionNames
- Procedure: Computed Tomography
- Other: Fludeoxyglucose F-18
- Radiation: Gallium Ga 68 FAPi-46
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)
- timeFrame
- Up to 2 years
- description
- Will be evaluated in normal and cancer tissues by standardized uptake values to determine where and to which degree 68Ga-FAPi-46 accumulates in normal and cancer tissues.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with the following suspected or diagnosed cancer types: * Adrenal cancer * Anal cancer * Bladder cancer * Brain cancer * Breast cancer * Cancer of unknown primary (CUP) * Cervical cancer * Cholangiocarcinoma * Colorectal cancer * Esophageal cancer * Gastric cancer * Head and neck cancer * Hematologic cancer * Hepatocellular carcinoma * Lung cancer * Medullary thyroid cancer * Neuroendocrine neoplasias * Ovarian cancer * Pancreatic cancer * Penile cancer * Peritoneal cancer * Pleural cancer * Prostate cancer * Sarcoma * Salivary gland cancer * Solitary fibrous tumor * Skin cancer * Testicular cancer * Thymus cancer * Thyroid cancer * Urothelial cancer * Uterus cancer * Vaginal cancer * Patients are ≥ 18 years old at the time of the radiotracer administration * Patient can provide written informed consent * Patient is able to remain still for duration of imaging procedure (up to one hour) Exclusion Criteria: * Patient is pregnant or nursing * 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