Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHuashan Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
[68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
RadiationThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: patients with solid tumorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors
The primary goal of the study is to evaluate the distribution profiles (in terms of SUVmax) of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors.
Time frame
1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T42
evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression
The secondary goal is to evaluate the sensitivity and specificity of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression.
Time frame
1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T43
evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT
The third goal is to evaluate the value of TROP-2 expression determined by \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT in differential diagnosis, patient selection, and response monitoring in patients with solid tumors.
Time frame
1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4Sponsors and contacts
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Source ClinicalTrials.gov