CD70-targeted immunoPET Imaging of Malignant Cancers

NCT ID: NCT06852638

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-23

Study Completion Date

2026-12-31

Brief Summary

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This study aims to establish and optimize the cluster of differentiation (CD70)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)) will be evaluated.

Detailed Description

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Histologically confirmed malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (NPC)), or patients with suspected maligant 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 treatment efficacy evaluation.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors 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 assess the diagnostic efficacy. The correlation between lesion uptake and CD70 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Conditions

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Renal Cancer Renal Clear Cell Carcinoma Lymphoma Lymphoma, Large B-Cell, Diffuse Follicular Lymphoma Mantle Cell Lymphoma Nasopharyngeal Carcinoma

Keywords

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The cluster of differentiation (CD70) ImmunoPET Renal Cancer Lymphoma Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CD70-targeted immunoPET imaging

Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.

Group Type EXPERIMENTAL

[18F]F-RESCA-RCCB6

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RCCB6 injection.

[18F]F-RESCA-R8B4

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]R8B4 injection.

[18F]F-RESCA-RD06

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RD06 injection.

[68Ga]Ga-NOTA-R8B4

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]R8B4 injection.

[68Ga]Ga-NOTA-RD06

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]RD06 injection.

[89Zr]Zr-DFO-RB6

Intervention Type DRUG

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-RB6 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

[89Zr]Zr-DFO-R8B4

Intervention Type DRUG

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-R8B4 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

[89Zr]Zr-DFO-RD06

Intervention Type DRUG

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-RD06 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

Interventions

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[18F]F-RESCA-RCCB6

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RCCB6 injection.

Intervention Type DRUG

[18F]F-RESCA-R8B4

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]R8B4 injection.

Intervention Type DRUG

[18F]F-RESCA-RD06

Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]RD06 injection.

Intervention Type DRUG

[68Ga]Ga-NOTA-R8B4

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]R8B4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]R8B4 injection.

Intervention Type DRUG

[68Ga]Ga-NOTA-RD06

Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]RD06. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]RD06 injection.

Intervention Type DRUG

[89Zr]Zr-DFO-RB6

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-RB6 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

Intervention Type DRUG

[89Zr]Zr-DFO-R8B4

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-R8B4 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

Intervention Type DRUG

[89Zr]Zr-DFO-RD06

Enrolled patients will receive a single dose (1-3 mCi) of \[89Zr\]Zr-DFO-RD06 (total 1-2 mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

Intervention Type DRUG

Other Intervention Names

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[18F]RCCB6 [18F]R8B4 [18F]RD06 [68Ga]R8B4 [68Ga]RD06 [89Zr]RB6 [89Zr]R8B4 [89Zr]RD06

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Pregnancy;
* Severe hepatic and renal insufficiency;
* Allergic to single-domain antibody radiopharmaceuticals.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianjun Liu, Ph.D. & M.D.

Role: STUDY_CHAIR

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

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

Role: PRINCIPAL_INVESTIGATOR

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

Phone: 15000083153

Email: [email protected]

Facility Contacts

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Weijun Wei

Role: primary

Shuxian An

Role: backup

Other Identifiers

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LY2024-306-A

Identifier Type: -

Identifier Source: org_study_id