RECRUITING

High-Resolution PET-CT Imaging for Surgical Margin Visualization

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol. Potential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins. Time Commitment: There are no additional visits that will be asked of you to partake in this study. Drug is FDA approved and Exposure to Radiation is minimal.

Official Title

High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study

Quick Facts

Study Start:2025-09-03
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06915454

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biopsy confirmed diagnosis of any solid malignancy
  2. * Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.
  3. * Planned standard of care oncologic surgery with curative intent
  4. * Male or female patients age ≥ 18 years
  5. * Have life expectancy of more than 12 weeks
  6. * Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
  7. * Have acceptable glucose status (\<200 mg/dL) at Day of Surgery prior to 18F-FDG injection
  1. * General or local contraindications for resective surgery
  2. * Women who are pregnant or breast-feeding
  3. * Blood glucose level over 200 mg/dL prior to 18F-FDG infusion
  4. * Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.

Contacts and Locations

Study Contact

Nicole Jones
CONTACT
615-936-2807
nicole.l.jones@vumc.org
Kyrionna Golliday
CONTACT
615-421-1585
kyrionna.m.golliday@vumc.org

Principal Investigator

Michael Topf, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt-Ingram Cancer Center

  • Michael Topf, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University/Ingram Cancer Center

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 Registration Dates

Study Start Date2025-09-03
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-09-03
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • undergoing surgery
  • Xeos
  • PET/CT imaging
  • specimen scanner
  • cancer margins

Additional Relevant MeSH Terms

  • Cancer
  • Solid Malignant Tumors