Back to results68Ga-PSMA PET in the Renal Cell Carcinoma
Primary Purpose
Renal Cancer, Metastases, PSMA PET
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PSMA PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Cancer focused on measuring advnaced renal cancer, PSMA PET, metastases
Eligibility Criteria
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.
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PSMA PET Arm
Arm Description
The PSMA PET arm received PSMA PET and enhanced CT at the same time in the diagnosis of the patients with suspected renal cancer.
Outcomes
Primary Outcome Measures
Additional diagnostic value of 68Ga PSMA PET / CT compared with CT in patients with locally advanced and advanced renal cell carcinoma
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA PET/CT compared with enhanced CT in diagnosing locally advanced and advanced renal cell carcinoma metastases in clinical practice. If the diagnostic performance of 68Ga PSMA PET / CT is better than enhanced CT, it may have additional diagnostic value in in locally advanced and advanced renal cell carcinoma.
Secondary Outcome Measures
The changes of treatment decision-making in patients with locally advanced and advanced renal cell carcinoma by 68Ga PSMA PET / CT.
The impact of 68Ga-PSMA PET/CT on clinical decisions in patients with locally advanced (Stage III) and advanced renal cell carcinoma (Stage IV) were evaluated by a multidisciplinary prostate cancer therapy team. The clinical decisions were made according to the EAU and NCCN guidelines. The patients with locally advanced (Stage III) has no metastases and advanced renal cell carcinoma (Stage IV) may have oligometastatic disease or metastatic disease. For the patients with locally advanced renal cell carcinoma (Stage III), radical nephrectomy or partial nephrectomy is appropriate. For the patients with advanced renal cell carcinoma (Stage IV), the patients with potentially surgically resectable RCC can receive surgery and the patients with unresectable RCC need to receive systemic therapy and rediotherapy. The different staging performance of enhanced CT and 68Ga-PSMA PET/CT may have impact on patients with locally advanced and advanced renal cell carcinoma.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04987086
Brief Title
68Ga-PSMA PET in the Renal Cell Carcinoma
Official Title
A Single Center Prospective Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer, Metastases, PSMA PET
Keywords
advnaced renal cancer, PSMA PET, metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PSMA PET Arm
Arm Type
Experimental
Arm Description
The PSMA PET arm received PSMA PET and enhanced CT at the same time in the diagnosis of the patients with suspected renal cancer.
Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA PET
Intervention Description
PSMA PET may have influence on the clinical decision-making of the patients with renal cancer
Primary Outcome Measure Information:
Title
Additional diagnostic value of 68Ga PSMA PET / CT compared with CT in patients with locally advanced and advanced renal cell carcinoma
Description
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA PET/CT compared with enhanced CT in diagnosing locally advanced and advanced renal cell carcinoma metastases in clinical practice. If the diagnostic performance of 68Ga PSMA PET / CT is better than enhanced CT, it may have additional diagnostic value in in locally advanced and advanced renal cell carcinoma.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The changes of treatment decision-making in patients with locally advanced and advanced renal cell carcinoma by 68Ga PSMA PET / CT.
Description
The impact of 68Ga-PSMA PET/CT on clinical decisions in patients with locally advanced (Stage III) and advanced renal cell carcinoma (Stage IV) were evaluated by a multidisciplinary prostate cancer therapy team. The clinical decisions were made according to the EAU and NCCN guidelines. The patients with locally advanced (Stage III) has no metastases and advanced renal cell carcinoma (Stage IV) may have oligometastatic disease or metastatic disease. For the patients with locally advanced renal cell carcinoma (Stage III), radical nephrectomy or partial nephrectomy is appropriate. For the patients with advanced renal cell carcinoma (Stage IV), the patients with potentially surgically resectable RCC can receive surgery and the patients with unresectable RCC need to receive systemic therapy and rediotherapy. The different staging performance of enhanced CT and 68Ga-PSMA PET/CT may have impact on patients with locally advanced and advanced renal cell carcinoma.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Jia
Phone
+86 029 8477 1794
Email
jiayanyan-2004@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
68Ga-PSMA PET in the Renal Cell Carcinoma
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