Comparison of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT in Patients With Various Types of Cancer

To evaluate the potential usefulness of 68Ga-DOTA-2P(FAPI)2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 68Ga-DOTA-FAPI-46 PET/CT.

Study Overview

• Status: Completed
• Conditions: Tumor, Solid, FAPI, PET/CT, Metastasis
• Intervention / Treatment: Diagnostic test: 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT

Detailed Description

In order to enhance the tumor uptake and tumor retention time, we designed the dimer structure of fibroblast activation protein inhibitor (FAPI), a novel imaging agent that targeting cancer-associated fibroblasts expressed in various types of cancer, 68Ga-DOTA-2P(FAPI)2. Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-2P(FAPI)2 and 68Ga-DOTA-FAPI-46 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haojun Chen, PhD; Phone Number: 18659285282; Email: leochen0821@foxmail.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (i) adult patients (aged 18 years or order);
• (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
• (iii) patients who had scheduled both 8Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT PET/CT scans;
• (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

• (i) patients with non-malignant lesions;
• (ii) patients with pregnancy;
• (iii)the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

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-2P(FAPI)2 PET/CT; Each subject receive a single intravenous injection of and 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2, and undergo PET/CT imaging within the specified time.	Diagnostic test: 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT; Each subject receive a single intravenous injection of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2, 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-FAPI-46 / 68Ga-DOTA-2P(FAPI)2 for each primary tumor of subject or suspected lymph metastasis.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The sensitivity of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT	30 days
Specificity	The specificity of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT	30 days
The positive predictive value (PPV)	The positive predictive value (PPV) of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT	30 days
The negative predictive value (NPV)	The negative predictive value (NPV) of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT	30 days
The accuracy	The accuracy of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT	30 days
Radiation Dosimetry	Mean absorbed radiation doses were estimated using the source and target organ framework. Five patients with different cancers underwent serial 68Ga-DOTA-2P(FAPI)2 PET/CT scans at three time points following radiotracer injection: 10 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: The First Affiliated Hospital of Xiamen University
• Investigators: Study Director: Long Sun, PhD, The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Diagnosis, Tumor, Solid, FAPI, PET/CT, Metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; FAPI-46
• Other Study ID Numbers: XMYY-2020KY042

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