Trop2-targeted immunoPET Imaging of Solid Tumors

Sponsor
RenJi Hospital
Study ID
NCT06851663
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]Ga-NOTA-T4 — DRUG
    Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.
  • [68Ga]Ga-NOTA-RT4 — DRUG
    Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RT4 injection.
  • [18F]F-RESCA-T4 — DRUG
    Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.
  • [18F]F-RESCA-RT4 — DRUG
    Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RT4 injection.

Study Details

This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.

Key Dates

First listed
Feb 28, 2025
Start date
Dec 23, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Trop2-targeted immunoPET imaging
    Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.

Primary Outcome Measure

Biodistribution-Standardized uptake value (SUV) of normal tissues and organs. [ Time Frame: 1 day from injection of the tracers ]

Central Contacts

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