Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

a study on Bladder Cancer Cervical Cancer Cholangiocarcinoma Hematopoietic and Lymphoid Cell Neoplasm Hepatocellular Carcinoma Liver Cancer Malignant Adrenal Gland Neoplasm Brain Tumor Malignant Pleural Neoplasm Skin Cancer/Melanoma Malignant Solid Neoplasm Testicular Cancer Malignant Thymus Neoplasm Neuroendocrine Neoplasm Thyroid Cancer Transitional Cell Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Jeremie Calais (ucla)

Description

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.

Official Title

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

Details

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 correlation of 68Ga-FAPI-46 biodistribution with 18F-fluodeoxyglucose (FDG), 68Ga-DOTATATE, or 18F-DOPA (FDOPA), depending on the specific indication. OUTLINE: Patients receive 68Ga-FAPi-46 intravenously (IV) then 20-90 minutes later undergo PET/computed tomography (CT).

Keywords

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 Carcinoma Neoplasms Brain Neoplasms Urinary Bladder Neoplasms Neuroendocrine Tumors Thyroid Neoplasms Skin Neoplasms Testicular Neoplasms Pleural Neoplasms Adrenal Gland Neoplasms Thymus Neoplasms FAPI-46 Computed Tomography Gallium Ga 68 FAPi-46 Positron Emission Tomography Basic science (68GA-FAPI-46 PET/CT)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • Patient is pregnant or nursing
  • Patients with any new cancer therapy between the baseline PET/CT and the investigational FAPI PET/CT

Location

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

  • Jeremie Calais (ucla)
    HS Associate Clinical Professor, Molecular and Medical Pharmacology, Medicine. Authored (or co-authored) 89 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT04459273
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated