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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.


Clinical Trial 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). ;


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

NCT number NCT04459273
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact Ethan Lam
Phone 310-206-7372
Email eclam@mednet.ucla.edu
Status Recruiting
Phase Phase 1
Start date August 27, 2020
Completion date July 1, 2025

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