RECRUITING

18F-Fluciclovine PET-MRI in High-grade Glioma

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

The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.

Official Title

Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)

Quick Facts

Study Start:2023-08-07
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05553041

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:1 Year to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
  2. * 2. Pregnant or breastfeeding participants.
  3. * 3. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC).
  4. * 4. Participants who weigh less than 8 kg.
  5. * 5. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
  6. * 6. Participants with a history of abnormal kidney function or creatinine \>= CTCAE v5.0 grade 2 at time of study registration.
  7. 7. Participants with primary tumors of the spinal cord.

Contacts and Locations

Study Contact

Mariam Aboian, MD, PhD
CONTACT
215-510-7661
aboianm@chop.edu
Nazanin Maleki, MD
CONTACT
malekin@chop.edu

Principal Investigator

Mariam Aboian, MD,PhD
PRINCIPAL_INVESTIGATOR
children's hospital of philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Mariam Aboian, MD,PhD, PRINCIPAL_INVESTIGATOR, children's hospital of philadelphia

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 Date2023-08-07
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-08-07
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Glioma
  • High Grade Glioma
  • Glioma, Malignant
  • Glioma Intracranial
  • Diffuse Glioma
  • 18F fluciclovine

Additional Relevant MeSH Terms

  • Glioma
  • High Grade Glioma
  • Glioma, Malignant
  • Glioma Intracranial
  • Diffuse Glioma