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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tumor, Solid, FAPI, PET/CT, Metastasis

Intervention / Treatment
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* Diagnostic Test: 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects with various types of cancer undergo contemporaneous 68Ga-DOTA-2P(FAPI)2 and 68Ga-DOTA-FAPI-46 PET/CT either for an initial assessment or for recurrence detection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-DOTA-2P(FAPI)2 PET/CT<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis, Tumor, Solid, FAPI, PET/CT, Metastasis