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

April 22, 2023 updated by: Chunjing Yu, Affiliated Hospital of Jiangnan University

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]SF-DEVD-2
Drug: [18F]SF-DEVD-2
Patients will receive a tracer dose of 18F (2-4mCi) labelled SF-DEVD-2
Drug: [18F]-FDG
Patients will receive a tracer dose of 18F (5-10mCi) labelled FDG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of tissue distribution of [18F]-DEVD-2
Time Frame: 7 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Jiangnan University

Investigators

  • Principal Investigator: Chunjing Yu, Affiliated Hospital of Jiangnan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 22, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 22, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS2023012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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