MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET Imaging in Solid Tumors

NCT06719856 | Not Yet Recruiting

• 1 other identifier: 2024YJZ143
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to construct a noninvasive approach using 68Ga-labeled bicyclic peptide radiotracer to detect the matrix metalloproteinase 14 (MMP14, MT1-MMP) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from MMP14 targeting treatment.

Conditions

Solid Tumor

Keywords

solid tumor; MMP14; MT1-MMP; PET imaging

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value（SUV）

  SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions. The uptake of the tracer （68Ga-MMP14） in solid tumor lesions by measuring SUV on PET/CT.

  2 years

Study Arms (1)

68Ga-MMP14

All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-MMP14 PET/CT scan.

Drug: 18-FDG

Interventions

18-FDG DRUG

All study participants will undergo one 18F-FDG PET/ CT scan.

68Ga-MMP14

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Malignant tumor patients or suspected patients

You may qualify if:

• Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;
• age ≥18 and ≤75 years old, male or female;
• ECOG score 0 or 1;
• expected survival time ≥6 months;
• There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;
• Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;
• patients recommended by clinicians to undergo PET/CT examination for tumor staging;
• The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.

You may not qualify if:

• Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.
• Individuals known or suspected to be allergic to the investigational drug or any of its components.
• Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \> 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) \> 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) \> 2.5 × 40 µmol/L, or serum creatinine \> 1.5 × 130 µmol/L.
• Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
• Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Central Study Contacts

Hua Zhu

CONTACT

010-88196495; zhuhuabch@pku.edu.cn

Zhi Yang

CONTACT

010-88196196; pekyz@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)