Positron Emission Tomograph(PET) Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy

NCT ID: NCT05828238

Last Updated: 2023-04-25

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

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-01-31

Brief Summary

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This is a single arm study to determining the value of apoptotic molecular probe SF-DEVD-2 in the early evaluation of tumor efficacy and comparing it head-to-head wihe 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose)

Detailed Description

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Conditions

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Breast Cancer Stage II Breast Cancer Stage III Solid Tumor

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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[18F]SF-DEVD-2

Group Type EXPERIMENTAL

[18F]SF-DEVD-2

Intervention Type DRUG

Patients will receive a tracer dose of 18F (2-4mCi) labelled SF-DEVD-2

[18F]-FDG

Intervention Type DRUG

Patients will receive a tracer dose of 18F (5-10mCi) labelled FDG

Interventions

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[18F]SF-DEVD-2

Patients will receive a tracer dose of 18F (2-4mCi) labelled SF-DEVD-2

Intervention Type DRUG

[18F]-FDG

Patients will receive a tracer dose of 18F (5-10mCi) labelled FDG

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients voluntarily signed informed consent;
2. Age18-70, male or female;
3. Diagnosed with stage 2 or 3 breast cancer
4. Solid tumors、masses larger than 2cm with lymph node metastasis
5. Pathology is HER3+、triple negative patients
6. Patients to be treated with neoadjuvant chemotherapy

Exclusion Criteria

1. Age greater than or equal to 70 years old
2. Abnormal liver and kidney function (more than five times the normal value)
3. Diagnosis level of breast cancer stage 4 or second time tumor patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role lead

Responsible Party

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Chunjing Yu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunjing Yu

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiangnan University

Locations

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Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunjing Yu

Role: CONTACT

15312238622

Facility Contacts

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Chunjing Yu

Role: primary

15312238622

Other Identifiers

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LS2023012

Identifier Type: -

Identifier Source: org_study_id

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