Actively Recruiting
Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
Led by Huashan Hospital · Updated on 2024-06-18
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early diagnostic effectiveness of two imaging agents, [68Ga]Ga-NOTA-T4 and [18F]AlF-RESCA-T4, in patients with pancreatic cancer, breast cancer, head and neck cancer, lung cancers, and other solid tumors. This study aims to develop a new noninvasive method for detecting these cancers by targeting a protein called TROP-2. The imaging will also be integrated with TROP-2-targeted therapies in some patients to assist in treatment selection and monitoring. Participants will receive a single intravenous injection of either [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4, with the dose calculated based on body weight at 3.7 MBq per kilogram. PET/CT imaging will be performed one hour after injection to visualize TROP-2 expression. This approach helps to assess the presence of cancer cells and their response to targeted treatment. During the study, participants will undergo PET/CT scans one hour after the tracer injection to evaluate safety and imaging effectiveness. Researchers will measure the sensitivity and specificity of the imaging agents in detecting TROP-2 expression. The study involves patients diagnosed with colorectal cancer confirmed by pathology, and safety monitoring will include assessing liver and kidney function. Participation lasts for the imaging procedure and related assessments, with no long-term treatment involved.
CONDITIONS
Brief Title
Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 65 years of age and of either sex.
- Patients with colorectal cancer confirmed by puncture or surgical pathology.
- Signed written informed consent by the subject or legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of this study.
You will not qualify if you...
- Severe hepatic or renal insufficiency.
- Targeted therapy before radiotherapy or PET/CT scan.
- Renal function: serum creatinine above the normal range.
- Liver function: bilirubin, AST(SGOT)/ALT(SGPT) above the normal range.
- History of serious surgery in the last month.
- Participation in other clinical trials during the same period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo a PET/CT imaging procedure using [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 to visualize TROP-2 expression in solid tumors.
1 imaging visit (in-person)
Trial Site Locations
Total: 1 location
1
Huashan Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yihui Guan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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