68Ga-PSMA PET in the Renal Cell Carcinoma

NCT ID: NCT04987086

Last Updated: 2024-01-26

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

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-06-01

Brief Summary

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The primary research purpose is to evaluate the diagnostic efficacy of 68Ga-PSMA PET in metastatic lesions of locally advanced and advanced renal cell carcinoma, and to compare with that of enhanced CT. The second purpose is to evaluate whether 68Ga-PSMA PET can change the treatment decision of patients with locally advanced and advanced renal cell carcinoma

Detailed Description

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Conditions

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Renal Cancer Metastases PSMA PET

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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PSMA PET Arm

The PSMA PET arm received PSMA PET and enhanced CT at the same time in the diagnosis of the patients with suspected renal cancer.

Group Type EXPERIMENTAL

PSMA PET

Intervention Type DIAGNOSTIC_TEST

PSMA PET may have influence on the clinical decision-making of the patients with renal cancer

Interventions

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PSMA PET

PSMA PET may have influence on the clinical decision-making of the patients with renal cancer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 2017 AJCC renal cell carcinoma TNM stage III, IV lesions;
* In contrast-enhanced CT staging, suspicious metastases were found;
* There were no known peripheral or central venous problems;
* 68Ga PSMA PET / CT imaging can be performed within 6 weeks after the diagnosis of renal cell carcinoma;
* Signed the informed consent form of voluntary participation in clinical trials.

Exclusion Criteria

* Age ≤ 18 years old;
* Can't stand lying flat in PET / CT examination;
* There are contraindications for 68Ga PSMA ligands;
* In the past two years, there was a history of other malignant tumors, or according to the doctor's research judgment, complications may occur and affect the normal operation of the test;
* Renal function is impaired or hemodialysis is in progress.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qin Weijun

Professor and Director, Department of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hospital

Xi'an, Shaan'xi, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yanyan Jia

Role: primary

+86 029 8477 1794

Other Identifiers

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KY20212033-F-1

Identifier Type: -

Identifier Source: org_study_id

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