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

NCT ID: NCT06719856

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20-30 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.

Conditions

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Solid Tumor

Keywords

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solid tumor MMP14 MT1-MMP PET imaging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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68Ga-MMP14

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

18-FDG

Intervention Type DRUG

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

Interventions

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18-FDG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;
2. age ≥18 and ≤75 years old, male or female;
3. ECOG score 0 or 1;
4. expected survival time ≥6 months;
5. 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;
6. 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;
7. patients recommended by clinicians to undergo PET/CT examination for tumor staging;
8. The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.

Exclusion Criteria

1. 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.
2. Individuals known or suspected to be allergic to the investigational drug or any of its components.
3. 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.
4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Hua Zhu

Role: CONTACT

Phone: 010-88196495

Email: [email protected]

Zhi Yang

Role: CONTACT

Phone: 010-88196196

Email: [email protected]

Facility Contacts

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Hua Zhu

Role: primary

Other Identifiers

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2024YJZ143

Identifier Type: -

Identifier Source: org_study_id