Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
Huashan Hospital
60 participants
Dec 1, 2023
INTERVENTIONAL
Conditions
Summary
This study will investigate the safety and preliminary diagnostic efficacy of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the treatment.
Eligibility
Inclusion Criteria4
- Be between 18 and 65 years of age and of either sex.
- Patients with colorectal cancer confirmed by puncture or surgical pathology.
- Written informed consent signed by the subject or legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of this study.
Exclusion Criteria4
- Severe hepatic or renal insufficiency;
- Targeted therapy before radiotherapy or PET/CT scan；
- Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range；
- History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.
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Interventions
The dose of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 was calculated based on the patient's body weight to be 3.7 MBq \[0.1 mCi\]/kg, and the method of administration was intravenous push, with one single imaging administration.
Locations(1)
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NCT06203574