AzTrials
AzTrials

Renal CancerPhase 2NCT06852638

CD70-targeted immunoPET Imaging of Malignant Cancers

A Phase 2 study testing [18F]F-RESCA-RCCB6, [18F]F-RESCA-R8B4 and [68Ga]Ga-NOTA-R8B4 in people with Renal Cancer and Renal Clear Cell Carcinoma, 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

This study aims to determine the value of cluster of differentiation (CD70)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging for diagnosing human malignancies, including renal cell carcinoma (particularly clear cell renal cell carcinoma), lymphoma, and nasopharyngeal carcinoma… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Renal Cancer, Renal Clear Cell Carcinoma, Lymphoma
What is being tested?
[18F]F-RESCA-RCCB6, [18F]F-RESCA-R8B4 and [68Ga]Ga-NOTA-R8B4
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
23 Dec 2024to 23 Dec 2026
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 renal cancer (especially ccRCC)/lymphoma/NPC or suspected renal cancer/lymphoma/NPC by diagnostic imaging;
  • Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.

Who cannot join

  • Pregnancy；
  • Severe hepatic and renal insufficiency;
  • Allergic to 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

China1 site, 1 recruiting

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

    Shanghai, 200127

    Weijun Wei, 15000083153, wwei@shsmu.edu.cn

    Shuxian An, 17717453484, anshuxian@shsmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: CD70-targeted PET/ CT in the Diagnosis of Malignant Cancers

This study aims to determine the value of cluster of differentiation (CD70)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging for diagnosing human malignancies, including renal cell carcinoma (particularly clear cell renal cell carcinoma), lymphoma, and nasopharyngeal carcinoma (NPC), among others.

Read the detailed description

Histologically confirmed malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) or patients with suspected malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and evaluation of treatment efficacy following the initial CD70-targeted immunoPET/CT imaging.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.01-0.1 mCi/kg). Uptake of imaging tracers in tumors and normal organs/tissues will be scored both visually and quantitatively.

Tumor uptake will be quantified using the maximum standard uptake value (SUVmax). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess diagnostic efficacy. The correlation between lesion uptake and CD70 expression levels, as determined by immunohistochemical staining, will be further analyzed. The primary exploratory endpoint will be the imaging feasibility of the tracers and their preliminary diagnostic value compared with conventional imaging approaches such as 18F-FDG PET/CT, CT/MRI. The secondary endpoint is the impact of CD70-targeted immunoPET/CT imaging on clinical decision-making.

Being tested
[18F]F-RESCA-RCCB6, [18F]F-RESCA-R8B4, [68Ga]Ga-NOTA-R8B4, [18F]F-RESCA-RD06, [68Ga]Ga-NOTA-RD06
Keywords
The cluster of differentiation (CD70), ImmunoPET, Renal Cancer, Lymphoma, Nasopharyngeal Carcinoma
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Nasopharyngeal Carcinoma

What participants receive

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

  • [18F]F-RESCA-RCCB6Drug

    Also called [18F]RCCB6

    Enrolled patients will receive 0.01-0.1 mCi/kg of [18F]RCCB6. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]RCCB6 injection.

  • [18F]F-RESCA-R8B4Drug

    Also called [18F]R8B4

    Enrolled patients will receive 0.01-0.1 mCi/kg of [18F]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]R8B4 injection.

  • [68Ga]Ga-NOTA-R8B4Drug

    Also called [68Ga]R8B4

    Enrolled patients will receive 0.01-0.1 mCi/kg of [68Ga]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]R8B4 injection.

  • [18F]F-RESCA-RD06Drug

    Enrolled patients will receive 0.01-0.1 mCi/kg of [18F]F-RESCA-RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RD06 injection.

  • [68Ga]Ga-NOTA-RD06Drug

    Enrolled patients will receive 0.01-0.1 mCi/kg of [68Ga]Ga-NOTA-RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RD06 injection.

Study groups in NCT06852638
Study groupRoleWhat they receive
CD70-targeted immunoPET imagingExperimentalEnrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
Receives: Drug: [18F]F-RESCA-RCCB6; Drug: [18F]F-RESCA-R8B4; Drug: [68Ga]Ga-NOTA-R8B4; Drug: [18F]F-RESCA-RD06; Drug: [68Ga]Ga-NOTA-RD06

What is being measured

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

  1. The uptake patterns of CD70-targeted tracers across different tumors

    Because the expression level of CD70 varies across tumors, including renal cell carcinoma (especially clear cell renal cell carcinoma), nasopharyngeal carcinoma, and lymphoma, due to different regulatory pathways, this variation will lead to differential uptake of CD70 tracers in these tumors. Therefore, the primary goal of the prospective study is to determine the uptake and distribution patterns of CD70-targeted tracers in patients with renal cell carcinoma (particularly clear cell), nasopharyngeal carcinoma, or lymphoma. To achieve this, imaging tracer uptake in tumors and normal organs/tissues will be scored both visually and quantitatively. Uptake will be correlated with CD70 expression determined by immunohistochemical staining.

    Measured: One month after the injection of the tracers

  2. The diagnostic value of CD70-targeted immunoPET/CT across different tumors

    The primary outcome of the prospective study is to determine the diagnostic value of CD70-targeted immunoPET/CT in human malignancies, especially renal cell carcinoma (with a focus on clear cell renal cell carcinoma), lymphoma, and nasopharyngeal carcinoma. To achieve this, tumor uptake will be quantified using the maximum standard uptake value (SUVmax). sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess diagnostic efficacy. The correlation between lesion uptake and CD70 expression levels, as determined by immunohistochemical staining, will be further analyzed. The comparative diagnostic value of CD70-targeted immunoPET/CT, relative to traditional imaging approaches such as 18F-FDG PET/CT and CT/MRI, will be assessed in selected patients.

    Measured: One month from the injection of the tracers

Secondary outcomes (1)

  1. The impact of CD70-targeted immunoPET/CT on clinical decision-making

    The secondary outcome of the study is to determine the impact of CD70-targeted immunoPET/CT on clinical decision-making, especially for patients with clear cell renal cell carcinoma.

    Measured: 3-6 months after the injection of the tracers

Timeline

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

  1. First posted28 Feb 2025
  2. Study start23 Dec 2024
  3. Primary completion23 Dec 2026 (estimated)
  4. Study completion23 Dec 2026 (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
NCT06852638
Sponsor's protocol ID
LY2024-306-A
Status last verified
May 2026
First submitted
16 Feb 2025
Last updated
12 May 2026
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]F-RESCA-RCCB6, [18F]F-RESCA-R8B4 and [68Ga]Ga-NOTA-R8B4 in people with Renal Cancer and Renal Clear Cell Carcinoma, 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 3 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 12 May 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.

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?

The uptake patterns of CD70-targeted tracers across different tumors (time frame: One month after the injection of the tracers). The study lists 2 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 NCT06852638.

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 12 May 2026.

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