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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04459273
Other study ID # 20-000630
Secondary ID NCI-2020-03766
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 27, 2020
Est. completion date July 1, 2025

Study information

Verified date July 2023
Source Jonsson Comprehensive Cancer Center
Contact Ethan Lam
Phone 310-206-7372
Email eclam@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: 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 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-) EXPERIMENTAL OBJECTIVE: To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available OUTLINE: 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 1, 2025
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - Cancer of Unkown Primary - Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis - 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 - Patients with any new cancer therapy between the baseline 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

Study Design


Related Conditions & MeSH terms

  • Adrenal Gland Neoplasms
  • Bladder Carcinoma
  • Brain Neoplasms
  • Cancer of Unknown Primary Site
  • 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
  • Neoplasms
  • Neoplasms, Unknown Primary
  • Neuroendocrine Neoplasm
  • Neuroendocrine Tumors
  • Pleural Neoplasms
  • Skin Neoplasms
  • Testicular Neoplasms
  • Thymus Neoplasms
  • Thyroid Gland Carcinoma
  • Thyroid Neoplasms
  • Urinary Bladder Neoplasms
  • Urothelial Carcinoma

Intervention

Procedure:
Computed Tomography
Undergo PET/CT
Drug:
Gallium Ga 68 FAPi-46
Given IV
Procedure:
Positron Emission Tomography
Undergo PET/CT
Radiation:
18F-FDG
Given IV

Locations

Country Name City State
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation. 60 minutes after tracer injection
Primary Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax). At 20-90 minutes after injection]
Secondary 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT) Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue. Up to year 2
Secondary 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution 2. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-) up to 2 years
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