68Ga-PSMA PET in the Renal Cell Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorXijing Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
PSMA PET
Diagnostic testPSMA PET may have influence on the clinical decision-making of the patients with renal cancer
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: PSMA PET ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 yearsSecondary outcomes
1
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.
Time frame
2 yearsSponsors and contacts
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Xijing Hospital
Lead sponsor
Air Force Military Medical University, China
Collaborator
Shaanxi Provincial People's Hospital
Collaborator
Yan'an University Affiliated Hospital
Collaborator
Weinan Central Hospital
Collaborator
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Collaborator
LanZhou University
Collaborator
Affiliated Hospital of Qinghai University
Collaborator
General Hospital of Ningxia Medical University
Collaborator
Source ClinicalTrials.gov