Renal Cell Carcinoma (RCC)NCT06916624
Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma (RCC) and Clear Cell Renal Cell Carcinoma (ccRCC), run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma (ccRCC)
- What is being tested?
- 18F-NY104 PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- Women planning pregnancy, currently pregnant, or lactating;
- Patients unable or unwilling to undergo PET/CT scanning;
- Other subjects deemed ineligible by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Jie Guang Yang, 0532-82913318, wangzhenguang@qde.edu.cn
About this study
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.
Read the 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.
- Being tested
- 18F-NY104 PET/CT
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-NY104 PET/CTRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-NY104 PET/CT scan | Not described Receives: Radiation: 18F-NY104 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start12 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, Weifang People's Hospital, Zibo Central Hospital, Affiliated Hospital of Jining Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916624
- Sponsor's protocol ID
- QDFY-NM-25003
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nie P, Li B, Luo L, Hou F, Zhang N, Yang H, Huang X, Zhu Z, Ma S, Wu T, Xie J, Zhang M, Yang G, Wang Z. A prospective head-to-head comparison of 18F-NYM005 PET/CT and 18F-FDG PET/CT in diagnosing renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2026 Jul;53(8):5002-5012. doi: 10.1007/s00259-026-07841-2. Epub 2026 Mar 20.
PubMed 41857358
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06916624
- Acronym / sponsor ID
- QDFY-NM-25003
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, Weifang People's Hospital, Zibo Central Hospital, Affiliated Hospital of Jining Medical University
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-NY104 PET/CT scan | – | Radiation: 18F-NY104 PET/CT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-NY104 PET/CTThe 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. | Radiation | 18F-NY104 PET/CT scan |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 41857358Nie P, Li B, Luo L, Hou F, Zhang N, Yang H, Huang X, Zhu Z, Ma S, Wu T, Xie J, Zhang M, Yang G, Wang Z. A prospective head-to-head comparison of 18F-NYM005 PET/CT and 18F-FDG PET/CT in diagnosing renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2026 Jul;53(8):5002-5012. doi: 10.1007/s00259-026-07841-2. Epub 2026 Mar 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma (RCC) and Clear Cell Renal Cell Carcinoma (ccRCC), run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact guang Zhen Wang (＋86-0532-82913318, wangzhenguang@qde.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06916624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.