99mTc Labeled FAP Targeted Molecular Probe In Early Diagnosis Of Tumors

Study Overview

99mTc Labeled FAP Targeted Molecular Probe in Early Diagnosis of Tumors

At present, radiopharmaceuticals targeting FAP have been developed for the diagnosis and treatment of various tumors. Considering the problems of fast tumor tissue clearance and short retention time in small molecule FAP inhibitors based on quinoline rings, this project optimized their ligands and developed a new FAP targeted technetium labeled molecular imaging probe for SPECT/CT imaging research to evaluate its safety in clinical application and its effectiveness in tumor diagnosis.

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Head and Neck Tumor
Lung Cancer
Pancreatic Cancer

DIAGNOSTIC_TEST: SPECT-CT imaging

KY20240419-08

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-05-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-07
First Submitted that Met QC Criteria 2024-05-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-11
First Posted (ACTUAL) 2024-06-03	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Tumor uptake	Compare the lesion site with surrounding normal tissue to evaluate whether there is a significant increase in radioactive uptake. Select the lesion in the abnormal area of the image and draw a 3D area of interest (ROI) to obtain the average lesion volume count (T). Calculate the tumor target/non target value (T/NT) statistically	1 hour after administering the probe

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Voluntary subjects, patients or their legal representatives sign informed consent;
Volunteers are of any gender and aged between 18 and 75 years old, including the cut-off value;
Other imaging methods found tumor occupying;
Patients with pre-treatment tumors for whom surgery or biopsy may be performed to obtain final pathological results.
Kidney glomerular filtration rate(GFR)>50 ml/min, effective renal plasma flow(ERPF)>280 ml/min, platelet count (PLT) >75 000/μL, white blood cell (WBC) >3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST less than 3 times the normal value.

People who have a history of allergy to similar drugs , allergic constitution or are currently suffering from allergic diseases;
Is conducting clinical research on other drugs, or has participated in clinical research on any drugs (excluding vitamins and minerals);
Have other clinical problems that are difficult to control (such as hepatitis C virus infection or active hepatitis B, or other serious chronic infections and serious mental, neurological, cardiovascular, respiratory and other diseases);
Obvious abnormal liver and kidney function, GFR less than 50 ml/min;
Tumor load is greater than 50%, or there is obvious spinal cord compression;
The expected survival period is less than half a year; Chemotherapy was performed within 6 months.
Have severe acute concomitant diseases or serious refractory mental disorders;
Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy study);
Patients whose physical condition is not suitable for radiological examination;
Other situations deemed inappropriate by the investigator to participate in the trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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