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Urologic NeoplasmsPhase 2NCT06680089

CD70-targeted immunoPET Imaging of Kidney Cancer

A Phase 2 study testing [18F]RCCB6 in people with Urologic Neoplasms and Urogenital Neoplasms, run by RenJi Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to establish and optimize the [18F]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
[18F]RCCB6
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
27 Nov 2024to Nov 2027
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-80 year-old and of either sex；
  • Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging;
  • Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Who cannot join

  • Pregnancy；
  • Severe hepatic and renal insufficiency;
  • History of serious surgery in the last month;
  • Allergic to antibody or single-domain antibody radiopharmaceuticals.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weijun Wei, Ph.D. & M.D. contact

15000083153

wwei@shsmu.edu.cn

Wei Zhai, Ph.D. & M.D. contact

18701771959

jacky_zw2002@hotmail.com

China1 site, 1 recruiting

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127

    Weijun Wei, Ph.D. & M.D., 15000083153, wwei@shsmu.edu.cn

    Wei Zhai, Ph.D. & M.D., 18701771959, jacky_zw2002@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Study of the Clinical Application of [18F]RCCB6 PET/ CT Imaging in the Diagnosis of Kidney Cancer

The aim of this study is to establish and optimize the [18F]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.

Read the detailed description

Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging will be included. Especially patients with suspected metastases or routine follow-up or surveillance or suitable for systemic treatments (e.g., combined immunotherapy and targeted therapies) will undergo [18F]RCCB6 immunoPET/CT scans. Enrolled patients will undergo whole-body [18F]RCCB6 immunoPET/CT scans at 1 hour after tracer injection(0.05-0.1 mCi/kg). Uptake of [18F]RCCB6 in tumor and normal organs/tissues will be scored visually and quantitatively. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. Furthermore, we will compare the diagnostic rates of [18F]RCCB6 immunoPET/CT with those of conventional imaging examinations, such as CT, MRI, and 18F-FDG PET/CT, etc.The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. Further explore the value of [18F]RCCB6 in treatment decision-making（staging, surveillance, and restaging） for kidney cancer.We will conduct an interim assessment when more than half of the patients have been enrolled.

Being tested
[18F]RCCB6
Keywords
The cluster of differentiation (CD70), Kidney tumor, Clear cell renal cell carcinoma, ImmunoPET
Medical subject headings
Urologic Neoplasms, Urogenital Neoplasms, Kidney Neoplasms, Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]RCCB6Drug

    Also called [18F]F-RESCA-RCCB6

    Enrolled patients will receive 0.05-0.1mCi/kg of [18F]RCCB6. ImmunoPET/CT imaging will be acquired 1 hour after [18F]RCCB6 injection.

Study groups in NCT06680089
Study groupRoleWhat they receive
CD70-targeted immunoPET imagingExperimentalEnrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
Receives: Drug: [18F]RCCB6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biodistribution of [18F]RCCB6

    Measurement of the overall biodistribution of [18F]RCCB6 in normal tissues and organs.

    Measured: 1 day from injection of the tracer

  2. Standardized uptake value (SUV)

    Standardized uptake value (SUV) of [18F]RCCB6 in the included subjects' primary and/or metastatic lesions.

    Measured: 1 day from injection of the tracer

  3. The correlation between CD70 expression and [18F]RCCB6 uptake value

    The Standardized uptake value (SUV) of [18F]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of [18F]RCCB6 will be analyzed.

    Measured: 60 days

  4. Diagnostic value of [18F]RCCB6 PET in patients with ccRCC

    We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of [18F]RCCB6 PET/CT in patients with ccRCC. We will also compare the diagnostic value of [18F]RCCB6 with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., CT and MRI). All the above goals will be achieved by analyzing the static/dynamic [18F]RCCB6 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of [18F]RCCB6 PET/CT for patients with ccRCC.

    Measured: 30 days

  5. To explore the diagnostic performance of [18F]RCCB6 PET with that of conventional imaging and [18F]FDG PET

    Using pathological or follow-up imaging data as the gold standard, explore the diagnostic performance of [18F]RCCB6 PET compared to conventional imaging and [18F]FDG PET.

    Measured: 6 months

Secondary outcomes (1)

  1. [18F]RCCB6 PET/CT in changing clinical decision-making for ccRCC patients

    After analyzing the imaging parameters and diagnostic/predictive value of [18F]RCCB6 PET/CT, we will also investigate how clinical use of [18F]RCCB6 PET/CT changes clinical decision-making for ccRCC patients. Joint efforts from nuclear medicine physicians, urologists, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start27 Nov 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06680089
Sponsor's protocol ID
LY2024-138-A
Status last verified
Dec 2025
First submitted
6 Nov 2024
Last updated
31 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [18F]RCCB6 in people with Urologic Neoplasms and Urogenital Neoplasms, run by RenJi Hospital 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 3 inclusion and 4 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 31 Dec 2025. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Weijun Wei, Ph.D. & M.D. (15000083153, wwei@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biodistribution of [18F]RCCB6 (time frame: 1 day from injection of the tracer). The study lists 5 primary outcomes in all. 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 NCT06680089.

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 31 Dec 2025.

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