An interventional study of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT in Tumor, Solid, FAPI, PET/CT, Metastasis, sponsored by The First Affiliated Hospital of Xiamen University. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Diagnostic
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.
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 7 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
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Exclusion Criteria:
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.
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.
Time frame: 30 days
Sensitivity
The sensitivity of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
Time frame: 30 days
Specificity
The specificity of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
Time frame: 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
Time frame: 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
Time frame: 30 days
The accuracy
The accuracy of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
Time frame: 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.
Time frame: 30 days
Plan to share: No
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Xiamen University