Clinical trial · Interventional
A Study Evaluating the Value of 68Ga-NOTA-RCCB6 PET Imaging for Targeting CD70 in the Clinical Staging, Therapeutic Evaluation, and Restaging of Renal Cell Carcinoma, and Comparing It with 68Ga-PSMA PET/CT Imaging
A Prospective, Open-label, Single-center Study of CD70-Specific PET/CT Imaging for Non-invasive Diagnosis of Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, open-label, single-center clinical study targeting renal cell carcinoma. Sixty patients with a high clinical suspicion of renal cell carcinoma were included. Qualified subjects will undergo 68Ga-NOTA-RCCB6 PET/CT examination. The aim is to establish the optimal imaging protocol; evaluate the distribution characteristics and correlations of physiological and pathological positive uptake, and using pathological results as the gold standard, assess the diagnostic efficacy of 68Ga-NOTA-RCCB6 PET/CT in renal cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| RCC, Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NOTA-RCCB6 PET/CT Scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- before-after study in the same patient
- description
- This is a prospective, open-label, single-center clinical study for renal cell carcinoma. Sixty patients clinically suspected of having renal cell carcinoma and undergoing 68Ga-PSMA PET scans were included. Qualified subjects underwent 68Ga-NOTA-RCCB6 PET scans within 7 days after completing the 68Ga-PSMA PET scan. Patient medical history was collected and laboratory tests were performed before the examination, and a biopsy or surgery was performed to obtain pathological results within 1 month after the examination, followed by a 6-month follow-up. The pathological results were used as the diagnostic gold standard.
- interventionNames
- Diagnostic Test: 68Ga-NOTA-RCCB6 PET/CT Scan
Primary outcomes (4)
- measure
- Maximum Standardized uptake value (SUVmax)
- timeFrame
- 1 day from injection of the tracer
- description
- Maximum Standardized uptake value (SUVmax) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' primary and/or metastatic lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: \- The subject or legal guardian/caregiver must voluntarily sign the informed consent form. Ages 18 to 75 years old. Patients with suspected renal cell carcinoma based on conventional imaging studies, and who undergo 68Ga-PSMA PET/CT scanning. Patients with suspicious lymph nodes or distant metastases detected by conventional imaging or 68Ga-PSMA PET/CT. Willing and able to follow the study protocol. Exclusion Criteria: \- Patients who have received anti-tumor treatment prior to PET/CT scan. Suffer from severe other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, respiratory system, immunodeficiency and other serious diseases. Alternative subjects have contraindications to PET/CT scanning. Including but not limited to: those who cannot tolerate repeated intravenous injections; those who may be allergic to the drug and its components (including those with a history of severe allergies or allergic reactions, especially those with allergies to the tested drug); claustrophobia. In the past year, diagnosed with other malignant tumors; alternative subjects have undergone major surgery in the past 3 months; received experimental drug or device treatment with unclear effects or safety within the past month, or have participated in other interventional clinical trials. Pregnant or lactating women. Patients who are lost to follow-up. Other conditions that, in the researcher's assessment, may affect the study or make the subject unsuitable for participation in the study.
References
Publications (0)
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