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

Primary Purpose

Breast Cancer Stage II, Breast Cancer Stage III, Solid Tumor

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

[18F]SF-DEVD-2

[18F]-FDG

About this trial

This is an interventional diagnostic trial for Breast Cancer Stage II

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients voluntarily signed informed consent; Age18-70, male or female; Diagnosed with stage 2 or 3 breast cancer Solid tumors、masses larger than 2cm with lymph node metastasis Pathology is HER3+、triple negative patients Patients to be treated with neoadjuvant chemotherapy Exclusion Criteria: Age greater than or equal to 70 years old Abnormal liver and kidney function (more than five times the normal value) Diagnosis level of breast cancer stage 4 or second time tumor patients

Sites / Locations

Affiliated Hospital of Jiangnan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]SF-DEVD-2

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of tissue distribution of [18F]-DEVD-2

Biodistribution of [18F] -DEVD-2 evaluated by the maximum standardized uptake value（SUVmax) in various organs during repeated [18F]-DEVD scans will be reported.

Secondary Outcome Measures

Full Information

NCT ID

NCT05828238

First Posted

April 11, 2023

Last Updated

April 22, 2023

Sponsor

Affiliated Hospital of Jiangnan University

1. Study Identification

Unique Protocol Identification Number

NCT05828238

Brief Title

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

Official Title

PET Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Affiliated Hospital of Jiangnan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Stage II, Breast Cancer Stage III, Solid Tumor

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

[18F]SF-DEVD-2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

[18F]SF-DEVD-2

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

[18F]-FDG

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluation of tissue distribution of [18F]-DEVD-2

Description

Biodistribution of [18F] -DEVD-2 evaluated by the maximum standardized uptake value（SUVmax) in various organs during repeated [18F]-DEVD scans will be reported.

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chunjing Yu

Phone

15312238622

ycj_wxd1978@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunjing Yu

Organizational Affiliation

Affiliated Hospital of Jiangnan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Affiliated Hospital of Jiangnan University

City

Wuxi

State/Province

Jiangsu

ZIP/Postal Code

214000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chunjing Yu

Phone

15312238622

ycj_wxd1978@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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