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BRIEF TITLE: PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation

PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation

  • Org Study ID: 20-000630
  • Secondary ID: NCI-2020-03766,20-000630
  • NCT ID: NCT04459273
  • NCT Alias:
  • Sponsor: Jonsson Comprehensive Cancer Center - Other
  • Source: Jonsson Comprehensive Cancer Center

Brief Summary

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

Detailed Description


I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor
(FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.


I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission
tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.

II. To assess the correlation of 68Ga-FAPI-46 biodistribution with 18F-fluodeoxyglucose
(FDG), 68Ga-DOTATATE, or 18F-DOPA (FDOPA), depending on the specific indication.


Patients receive 68Ga-FAPi-46 intravenously (IV) then 20-90 minutes later undergo
PET/computed tomography (CT).

Overal Status Start Date Phase Study Type
Recruiting August 27, 2020 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues

Primary Outcome 1 - Time Frame: At 20-90 minutes after injection]


  • Bladder Carcinoma
  • Cervical Carcinoma
  • Cholangiocarcinoma
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Hepatocellular Carcinoma
  • Malignant Adrenal Gland Neoplasm
  • Malignant Brain Neoplasm
  • Malignant Pleural Neoplasm
  • Malignant Skin Neoplasm
  • Malignant Solid Neoplasm
  • Malignant Testicular Neoplasm
  • Malignant Thymus Neoplasm
  • Neuroendocrine Neoplasm
  • Thyroid Gland Carcinoma
  • Urothelial Carcinoma


Inclusion Criteria:

- Patients with the following cancer types:

- Brain cancer

- Bladder cancer

- Urothelial cancer

- Testicular cancer

- Skin cancer

- Thyroid cancer

- Hepatocellular carcinoma

- Cholangiocarcinoma

- Thymus cancer

- Pleural cancer

- Cervical cancer

- Adrenal cancer

- Neuroendocrine tumors

- Hematologic cancer

- Patients who underwent a staging PET/CT scan within 3 months of enrollment (with any
PET tracer related to the indication including FDG, DOTATATE, FDOPA)

- Patients who are scheduled to undergo surgical resection or tissue biopsy of the
primary tumor and/or metastasis

- 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

- Patients with any new cancer therapy between the baseline PET/CT and the
investigational FAPI PET/CT
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jeremie Calais

Role: Principal Investigator

Affiliation: UCLA / Jonsson Comprehensive Cancer Center

Overall Contact

Name: Stephanie Lira

Phone: 310-206-0596



Facility Status Contact
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United States
Recruiting Stepanie Lira