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Preoperative 68Ga-PSMA PET/CT on the efficacy of lymph node metastasis in clinical advanced/metastatic renal cancer

Preoperative 68Ga-PSMA PET/CT on the efficacy of lymph node metastasis in clinical advanced/metastatic renal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017152
Enrollment
Unknown
Registered
2018-07-13
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney cancer

Interventions

Gold Standard:Enhanced CT or PDG-PET/CT
Index test:PSMA-PET/CT

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The subject has clinical diagnosed of locally advanced/metastatic renal cancer, which conforms to any of the following: (1) T3-t4 stage tumor (tumor diameter greater than 10cm, accompanied by tumor thrombus and/or extraperitoneal invasion); (2) Preoperative imaging of renal hilum and/or retroperitoneal lymph node enlargement; (3) Accompanied by distant metastasis; 2. Primary renal cancer can be surgically removed; 3. The life expectancy is more than or equal to 3 months; 4. The subject is more than or equal to 18 years old; 5. The subject has 0-2 points according to ECOG; 6. Functions of major organs: No significant abnormalities are found in liver, kidney, bone marrow, heart and other important organs; 7. No significant abnormalities are found on ECG, or the abnormalities show no clinical significance; 8. Women of childbearing age must confirm non-pregnancy prior to enrollment. All enrolled subjects (male and female) must take adequate barrier methods for birth control during the entire treatment period and within 4 weeks after the end of treatment; 9. The subject must be capable of understanding and voluntarily signing the informed consent. The informed consent must be signed prior to any tests.

Exclusion criteria

Exclusion criteria: 1. Unable to perform primary nephrectomy and regional lymph node dissection; 2. The subject has received systematic treatment for metastatic renal cancer : targeted drug/immune/cytokine therapy; 3. Severe heart and cerebral vascular diseases, uncontrollable hypertension and diabetes, and incomplete renal function or renal failure; 4. HIV positive, or other immune deficiencies; 5. Clear history of metal illness, affecting his/her understanding of informed consent and compliance with study; 6. Other malignant tumors which have not been cured; 7. Women in pregnancy or lactation; 8. Any condition that is not stable or may jeopardize the safety of the subject and his/her compliance with the study; or other factors that the investigators believe that the subject is not suitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
predictive value;Sensibility;Specificity;Veracity;

Secondary

MeasureTime frame
Postive predictive value;Negative predictive value;positive likelihood ratio;negative liklihood ratio;odds ratio;omission diagnostic rate;misdiagnosis rate;

Countries

China

Contacts

Public ContactDong pei

Sun Yat-sen University Cancer Center

dongpei@sysucc.org.cn+86 13512738496

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026