Clinical trial NCT06438705: 99mTc Labeled FAP Targeted Molecular Probe in Early Diagnosis of Tumors
Official title: Clinical Application of a Novel 99mTc Labeled Fibroblast Activating Protein (FAP) Targeted Molecular Probe in Early Diagnosis of Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Tumor
Lung Cancer
Pancreatic Cancer
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was mainly conducted by SPECT CT imaging, and a total of 20 cases were planned to be enrolled, which were evaluated by 2 attending physicians of nuclear medicine or above according to various measurement data of the subjects

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Tumor uptake
timeFrame: 1 hour after administering the probe
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References: