Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University
About this trial
This study aims to evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET/CT in detecting primary, recurrent, and metastatic lesions of renal cell carcinoma (RCC), and to explore its potential for imaging and treatment response assessment in other CAIX-positive solid tumors, such as breast cancer and nasopharyngeal carcinoma, where high CAIX expression is associated with poor prognosis. The study will also investigate the effect of oral low-dose acetazolamide on the biodistribution of 18F-NY104, particularly in the stomach and kidneys.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements;
Age 18-75 years; no gender restrictions;
Clinically diagnosed/suspected renal cell carcinoma, clinically diagnosed/suspected recurrence and/or metastasis after treatment of renal cell carcinoma, or CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma;
At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1);
Disqualifiers
Recovery from major trauma (including surgery) within 4 weeks prior to study examination;
Patients with systemic or local severe infections or other serious comorbidities;
Severe hepatic or renal dysfunction;
Refusal to participate in this clinical study;
Trial population
The cohort primarily included patients who were clinically diagnosed with or suspected to have renal cell carcinoma (RCC), those with suspected recurrence or metastasis after treatment of RCC, and patients with CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
18F-NY104 PET/CT
RadiationThe radionuclide ¹⁸F will serve as the tracer in this study. NY104 will be labeled with \[¹⁸F\]AlF to form the ¹⁸F-NY104 injection for use in this research.All participants will undergo ¹⁸F-NY104 PET scan.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: 18F-NY104 PET/CT scan1 intervention
Trial outcomes
Primary outcomes
1
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Affiliated Hospital of Qingdao University
Lead sponsor
Qianfoshan Hospital
Collaborator
Weifang People's Hospital
Collaborator
Zibo Central Hospital
Collaborator
Affiliated Hospital of Jining Medical University
Collaborator
Source ClinicalTrials.gov