Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Kidney disease affects more than 500 million people worldwide, including approximately 120 million individuals in China. Among various kidney diseases, renal cell carcinoma (RCC) represents one of the most serious malignant conditions affecting the kidney and is one of the most common malignancies of the urinary system. The incidence of RCC in China has increased in recent years. Early-stage RCC is often asymptomatic and may be detected incidentally during routine health examinations. However, RCC is an aggressive malignancy, and a substantial proportion of patients present with metastatic disease at initial diagnosis or develop recurrence and metastasis after surgery. Therefore, accurate detection of primary, recurrent, and metastatic lesions is important for diagnosis, staging, restaging, treatment planning, and prognosis assessment.
Carbonic anhydrase IX (CAIX) is a transmembrane glycoprotein of the carbonic anhydrase family and is closely associated with the von Hippel-Lindau (VHL)/hypoxia-inducible factor (HIF) signaling pathway. By regulating intracellular and extracellular pH under hypoxic conditions, CAIX contributes to tumor cell survival, proliferation, invasion, and metastasis. CAIX has limited expression in most normal tissues but is highly expressed in RCC, particularly clear cell RCC, making it an attractive molecular target for tumor imaging and therapy. Moreover, CAIX overexpression is observed in a variety of other solid tumors, including breast cancer and nasopharyngeal carcinoma, and has been associated with tumor hypoxia, aggressive tumor characteristics, and poor prognosis. Thus, non-invasive assessment of CAIX expression may provide clinically relevant information for tumor detection, characterization, prognosis assessment, and treatment response evaluation in RCC and other CAIX-positive solid tumors.
18F-NY104 is a novel CAIX-targeted PET imaging agent with favorable radiochemical and imaging characteristics. Preclinical studies have demonstrated its specific binding to CAIX expressed on tumor cells, as well as favorable pharmacokinetics and imaging performance, supporting its potential for non-invasive, whole-body assessment of CAIX-positive tumors.
This study will evaluate the diagnostic performance of 18F-NY104 PET/CT for detecting primary, recurrent, and metastatic RCC lesions and explore its potential application in other CAIX-positive solid tumors, including breast cancer and nasopharyngeal carcinoma. Its potential value for non-invasive assessment of CAIX expression and treatment response will also be investigated. In addition, the study will evaluate the effect of oral low-dose acetazolamide, a CAIX inhibitor, on the biodistribution of 18F-NY104, particularly physiological uptake in the stomach and kidneys, and its potential impact on lesion visualization and image interpretation.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: guang Zhen Wang
- Phone Number: ＋86-0532-82913318
- Email: wangzhenguang@qde.edu.cn
Study Locations
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Shandong
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Qingdao, Shandong, China
- Recruiting
- The Affiliated Hospital of Qingdao University
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Contact:
- Jie Guang Yang
- Phone Number: 0532-82913318
- Email: wangzhenguang@qde.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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);
- ECOG performance status score of 0-2;
Laboratory parameters must meet:
- Hematology: WBC ≥4.0×10⁹/L or neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; PT or APTT ≤1.5×ULN (upper limit of normal);
- Liver and kidney function: T-Bil ≤1.5×ULN, ALT/AST ≤2.5×ULN or ≤5×ULN (for subjects with liver metastasis), ALP ≤2.5×ULN (if bone or liver metastasis is present, ALP ≤4.5×ULN); BUN ≤1.5×ULN, SCr ≤1.5×ULN;
- Other routine tests: Within normal ranges or deemed acceptable by the investigator;
- Expected survival ≥12 weeks;
- Female subjects: Effective contraception (defined as sterilization, intrauterine hormone device, condoms, contraceptives/agents, abstinence, or partner vasectomy) must be used during the study and for 6 months post-study; Male subjects: Agreement to use contraception during the study and for 6 months post-study.
Exclusion Criteria:
- 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;
- Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution;
- Childbearing-aged male or female subjects who cannot adopt effective contraception;
- Women planning pregnancy, currently pregnant, or lactating;
- Patients unable or unwilling to undergo PET/CT scanning;
- Other subjects deemed ineligible by the investigator.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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18F-NY104 PET/CT scan
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The 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SUV
Time Frame: 2 years
|
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
|
2 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Urologic Neoplasms
- Carcinoma
- Kidney Neoplasms
- Carcinoma, Renal Cell
Other Study ID Numbers
- QDFY-NM-25003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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