Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma

NCT ID: NCT07067905

Last Updated: 2025-07-16

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

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2026-06-01

Brief Summary

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A prospective, open-label, phase 1 study. This clinical trial aims to evaluate the diagnostic value of 68Ga-XT771, a CAIX/CAXII protein-specific probe, in PET/CT imaging for patients with clear cell renal cell carcinoma and glioblastoma. Safety, tolerability, and biodistribution characteristics of 68Ga-XT771 will also be assessed.

Detailed Description

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Conditions

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Clear Cell Renal Cell Carcinoma and Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Participant Group

Experimental: 68Ga-XT771 Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-XT771followed by PET imaging. The subjects will also receive a 18F-FDG PET/CT or 68Ga-DPI-4552 scan within a four-week period.

Pathologically confirmed glioblastoma subjects will receive intravenous administration of the CAIX/CAXII-targeted probe 68Ga-XT771, followed by PET imaging. Additionally, 11C-METHIONINE (11C-MET) PET scanning will be performed within a 4-week window

Drug: 68Ga-XT771 68Ga-XT771 is injected intravenously with a dose of 4-8 mCi

Group Type EXPERIMENTAL

68Ga-XT771

Intervention Type DRUG

68Ga-XT771 is injected intravenously with a dose of 4-8 mCi

Interventions

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68Ga-XT771

68Ga-XT771 is injected intravenously with a dose of 4-8 mCi

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. signed the informed consent 2. ≥18 years old 3. Patients with glioblastoma or clear cell renal cell carcinoma

Exclusion Criteria

* 1\. Known allergy to components of the investigational drug or its analogues 2. suspected to have a certain disease or condition that is not suitable for the study drug 3. Known pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sinotau Pharmaceutical Group

INDUSTRY

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ruimin Wang

Chinses PLA General Hospital, nuclear medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ruimin Wang

Role: CONTACT

+8613501151740

Facility Contacts

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Ruimin Wang

Role: primary

+8613501151740

Other Identifiers

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S2025-149-02

Identifier Type: -

Identifier Source: org_study_id

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