68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer

Clinical Applications of Fibroblast Activation Protein Inhibitor-Based Dimeric Radiotracer 68Ga-DOTA-F2 PET/CT Imaging for Malignant Tumors

To evaluate the potential usefulness of 68Ga-DOTA-F2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Study Overview

• Status: Recruiting
• Conditions: Tumor, Solid
• Intervention / Treatment: Diagnostic test: 68Ga-DOTA-F2 PET/CT and 18F-FDG

Detailed Description

Quinoline-based fibroblast activation protein (FAP) inhibitors (FAPIs; e.g., FAPI-04 and FAPI-46), which have shown promising results in the diagnosis of cancer and various other diseases in recent years, have become the focus of much productive research. Despite this, one major issue is that these FAPI molecules have a relatively short tumor retention time, which may limit their use in targeted radionuclide therapy applications. As a result, 68Ga-DOTA-F2, a novel dimeric FAPI molecule, was developed to increase tracer uptake and retention in tumors for potential therapeutic or theranostic applications. In preclinical study, 68Ga-DOTA-F2 has shown better tumor uptake and longer tumor retention time than 68Ga-FAPI in mouse tumor models. Our study will assess image quality and evaluate the diagnostic performance of 68Ga-DOTA-F2. Patients with histologically confirmed malignant tumors will be prospectively recruited in this study.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peipei Wang, MD; Phone Number: 18511395988; Email: wpp199411@163.com
• Study Contact Backup: Name: Fang Li, MD; Phone Number: 13901054627; Email: lifang@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10010
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Peipei Wang, MD; Phone Number: 18511395988; Email: wpp199411@163.com
      • Contact: Fang Li, MD; Phone Number: 13901054627; Email: lifang@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is aged 18 years or older
2. Signed Informed Consent
3. Subject is pathologically confirmed with a malignant tumor
4. Subject is judged to be in good general condition by the investigator based on medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of malignant tumor
5. Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with the negative pregnancy test

Exclusion Criteria:

1. Subject has a previous or ongoing recurrent or chronic disease, other than malignant tumor, at high risk to interfere with the evaluation of the trial according to the judgment of the investigator
2. Subject with non-malignant lesions;
3. Subject with the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Subject is potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-DOTA-F2 PET/CT and 18F-FDG; Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time.	Diagnostic test: 68Ga-DOTA-F2 PET/CT and 18F-FDG; Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized uptake value (SUV)	Standardized uptake value (SUV) of 68Ga-DOTA-F2 and 18F-FDG for each primary tumor of subject or suspected lymph metastasis	through study completion, an average of 1 year
Lession detection ability	Lession number detected by 68Ga-DOTA-F2 and 18F-FDG PET/CT	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The sensitivity of 68Ga-DOTA-F2 PET/CT and 18F-FDG PET/CT	through study completion, an average of 1 year
Specificity	The specificity of 68Ga-DOTA-F2 PET/CT and 18F-FDG PET/CT	through study completion, an average of 1 year
Radiation Dosimetry	Mean absorbed radiation doses were estimated using the source and target organ framework. Five patients with different cancers underwent serial 68Ga-DOTA-F2 PET/CT scans at five-time points following radiotracer injection: 5 minutes, 15 minutes, 30 minutes, 1 hour, and 3 hours. The source organs consisted of the kidneys, bladder, liver, heart, spleen, bone marrow, uterus, and body remainder. OLINDA/EXM software was used to fit and integrate the kinetic organ activity data to yield total body and organ time-integrated activity coefficients/residence times and finally organ absorbed doses.	30 days

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Fang Li, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Anticipated): September 15, 2023
• Study Completion (Anticipated): September 15, 2023

Study Registration Dates

• First Submitted: November 27, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: I-22PJ292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No