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

Last updated: March 7, 2025
Sponsor: Nanjing First Hospital, Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Lung Cancer

Non-small Cell Lung Cancer

Treatment

SPECT-CT imaging

Clinical Study ID

NCT06438705
KY20240419-08
  • Ages 18-75
  • All Genders

Study 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

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 thecut-off value;

  • Other imaging methods found tumor occupying;

  • Patients with pre-treatment tumors for whom surgery or biopsy may be performed toobtain final pathological results.

  • Kidney glomerular filtration rate(GFR)>50 ml/min, effective renal plasmaflow(ERPF)>280 ml/min, platelet count (PLT) >75 000/μL, white blood cell (WBC) >3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST less than 3times the normal value.

Exclusion

Exclusion Criteria:

  • People who have a history of allergy to similar drugs , allergic constitution or arecurrently suffering from allergic diseases;

  • Is conducting clinical research on other drugs, or has participated in clinicalresearch on any drugs (excluding vitamins and minerals);

  • Have other clinical problems that are difficult to control (such as hepatitis Cvirus infection or active hepatitis B, or other serious chronic infections andserious 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 performedwithin 6 months.

  • Have severe acute concomitant diseases or serious refractory mental disorders;

  • Pregnant and lactating women (where pregnancy is defined as a positive urinepregnancy study);

  • Patients whose physical condition is not suitable for radiological examination;

  • Other situations deemed inappropriate by the investigator to participate in thetrial.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: SPECT-CT imaging
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Active - Recruiting

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