Comparison of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT in Patients With Various Types of Cancer
- Conditions
- Tumor, Solid, FAPI, PET/CT, Metastasis
- Interventions
- Diagnostic Test: 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
- Registration Number
- NCT04941872
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- (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.
- (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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-DOTA-2P(FAPI)2 PET/CT 68Ga-DOTA-FAPI-46 and 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.
- Primary Outcome Measures
Name Time Method Standardized uptake value (SUV) 30 days Standardized uptake value (SUV) of 68Ga-DOTA-FAPI-46 / 68Ga-DOTA-2P(FAPI)2 for each primary tumor of subject or suspected lymph metastasis.
- Secondary Outcome Measures
Name Time Method The negative predictive value (NPV) 30 days The negative predictive value (NPV) of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
Specificity 30 days The specificity of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
Sensitivity 30 days The sensitivity of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
The positive predictive value (PPV) 30 days The positive predictive value (PPV) of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
The accuracy 30 days The accuracy of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
Radiation Dosimetry 30 days 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.
Trial Locations
- Locations (1)
The First affiliated hospital of xiamen university
🇨🇳Xiamen, Fujian, China