New imaging probe for early diagnosis of tumors

Clinical Application of a Novel 99mTc Labeled Fibroblast Activating Protein (FAP) Targeted Molecular Probe in Early Diagnosis of Tumors

This study is testing a new imaging tool to see if it can help doctors find tumors earlier in patients with head and neck tumors, lung cancer, and pancreatic cancer.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06438705 on ClinicalTrials.gov

What this trial studies

This observational study focuses on developing a technetium-labeled molecular imaging probe targeting fibroblast activation protein (FAP) for SPECT/CT imaging. The aim is to evaluate the safety and effectiveness of this new probe in diagnosing tumors, specifically in patients with head and neck tumors, lung cancer, and pancreatic cancer. By optimizing ligands to improve tumor tissue retention, the study seeks to enhance early detection of these cancers. Participants will undergo imaging to assess the probe's performance in identifying tumor presence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with pre-treatment tumors that require surgical or biopsy confirmation.

Not a fit: Patients with a history of allergies to similar drugs or those currently involved in other clinical research may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early diagnosis of various tumors, potentially increasing treatment options and outcomes for patients.

How similar studies have performed: While similar imaging approaches have been explored, this specific technetium-labeled probe represents a novel approach 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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)

Conditions Head and Neck Tumor; Lung Cancer; Pancreatic Cancer