Study Results
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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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-12-23
2026-12-31
Brief Summary
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Detailed Description
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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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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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CD70-targeted immunoPET imaging
Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
[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.
[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.
[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.
[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.
[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.
[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).
[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).
[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).
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.
[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.
[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.
[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.
[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.
[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).
[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).
[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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Severe hepatic and renal insufficiency;
* Allergic to single-domain antibody radiopharmaceuticals.
18 Years
80 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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