Positron Emission Tomograph(PET) Imaging Explores the Rol... | NCT05828238

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

NCT05828238

Sponsor

Affiliated Hospital of Jiangnan University

Status

Unknown status

Last Update Posted

Apr 25, 2023Actual

Enrollment

10Estimated

Phase

Early Phase 1

Conditions

Breast Cancer Stage II
Breast Cancer Stage III
Solid Tumor

Interventions

[18F]SF-DEVD-2
[18F]-FDG

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2023Actual

Primary Completion Date

Jan 2024Estimated

Completion Date

Jan 2024Estimated

First Submitted Date

Apr 11, 2023

First Submission Date that Met QC Criteria

Apr 22, 2023

First Posted Date

Apr 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2023

Last Update Posted Date

Apr 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chunjing Yu, Director, Affiliated Hospital of Jiangnan UniversityPrincipal Investigator

Lead Sponsor

Affiliated Hospital of Jiangnan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
[18F]SF-DEVD-2	Experimental		Drug: [18F]SF-DEVD-2 Drug: [18F]-FDG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[18F]SF-DEVD-2	Drug	Patients will receive a tracer dose of 18F (2-4mCi) labelled SF-DEVD-2	[18F]SF-DEVD-2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chunjing Yu	Contact	15312238622		ycj_wxd1978@163.com

Overall Officials

Name	Affiliation	Role
Chunjing Yu	Affiliated Hospital of Jiangnan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of Jiangnan University	Recruiting	Wuxi	Jiangsu	214000	China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019788	Fluorodeoxyglucose F18

Ancestor Terms

ID	Term
D003847	Deoxyglucose
D003837	Deoxy Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided