Clinical trial NCT04459273: Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Official title: PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
Cancer of Unknown Primary Site
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues
timeFrame: At 20-90 minutes after injection]
Secondary outcomes:
measure: 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)
timeFrame: Up to year 2
measure: 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
timeFrame: up to 2 years
Other outcomes:
measure: To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers
timeFrame: 60 minutes after tracer injection
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Jeremie Calais
role: PRINCIPAL_INVESTIGATOR
References: