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Target-specific immunoPET Imaging of Breast Cancer

NCT ID: NCT06715826

Last Updated: 2024-12-04

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-21

Study Completion Date

2026-11-30

Brief Summary

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The aim of this study is to establish and optimize the Trop2/HER2-targeted PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.

Detailed Description

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Enrolled patients will undergo whole-body \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4(Trop2-targeted imaging probes ) or \[68Ga\]Ga-DOTA-H2D3/\[18F\]F-RESCA-RB14(HER2-targeted imaging probes) PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents 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. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Conditions

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Breast Cancer Breast Neoplasms Breast Cancer Metastatic

Keywords

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Trop2 HER2 Breast Cancer ImmunoPET

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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Trop2/HER2-targeted immunoPET imaging

Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.

Group Type EXPERIMENTAL

[68Ga]Ga-NOTA-T4

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1 hour after \[68Ga\]Ga-NOTA-T4 injection.

[18F]F-RESCA-T4

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-T4 injection.

[68Ga]Ga-DOTA-H2D3

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1mCi/kg of \[68Ga\]Ga-DOTA-H2D3. ImmunoPET/CT imaging will be acquired 1 hour after \[68Ga\]Ga-DOTA-H2D3 injection.

[18F]F-RESCA-RB14

Intervention Type DRUG

Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-RB14. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-RB14 injection.

Interventions

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[68Ga]Ga-NOTA-T4

Enrolled patients will receive 0.05-0.1mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1 hour after \[68Ga\]Ga-NOTA-T4 injection.

Intervention Type DRUG

[18F]F-RESCA-T4

Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-T4 injection.

Intervention Type DRUG

[68Ga]Ga-DOTA-H2D3

Enrolled patients will receive 0.05-0.1mCi/kg of \[68Ga\]Ga-DOTA-H2D3. ImmunoPET/CT imaging will be acquired 1 hour after \[68Ga\]Ga-DOTA-H2D3 injection.

Intervention Type DRUG

[18F]F-RESCA-RB14

Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-RB14. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-RB14 injection.

Intervention Type DRUG

Other Intervention Names

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[68Ga]Ga-T4 [18F]F-T4 [68Ga]Ga-H2D3 [18F]F-RB14

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-75 years old and of female gender；
2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion Criteria

1. Pregnancy；
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

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

Role: STUDY_CHAIR

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, Shanghai Municipality, 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]

Wenzhi Jia, Ph.D. & M.D.

Role: CONTACT

Phone: 18317076979

Email: [email protected]

Facility Contacts

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

Role: primary

Wenzhi Jia, Ph.D. & M.D.

Role: backup

Other Identifiers

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KY2024-095-A

Identifier Type: -

Identifier Source: org_study_id