NCT05828238

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 11, 2023

Last Update Submit

April 22, 2023

Conditions

Breast Cancer Stage IIBreast Cancer Stage IIISolid Tumor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

[18F]SF-DEVD-2

EXPERIMENTAL
Drug: [18F]SF-DEVD-2Drug: [18F]-FDG

Interventions

[18F]SF-DEVD-2DRUG

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

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

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

[18F]SF-DEVD-2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Chunjing Yu

    Affiliated Hospital of Jiangnan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjing Yu

CONTACT

15312238622ycj_wxd1978@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 25, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

CN(1)