The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents

NCT03402425 | Unknown DMC

• 1 other identifier: 327-15
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the diagnostic value of 18F-FET PET/MRI instead of MRI alone, children and adolescents with tumor in brain or spinal cord are included and scanned primarily at our hybrid PET/MRI using the amino acid analog 18F-FET. The scans are performed at primary diagnosis, before radiation therapy, before and after operation, when relapse is suspected and three or six months after initiation of chemotherapy.

Conditions

Positron-Emission Tomography; Brain Neoplasms, Childhood

Keywords

FET; PET/MRI; child

Outcome Measures

Primary Outcomes (1)

• Change of treatment

  The treatment plan is changed based on the PET findings

  up to 3 months

Secondary Outcomes (2)

• Sensitivity and specificity

  up to 3 months

• Recurrence free survival time

  at least one year

Study Arms (1)

All included patients

EXPERIMENTAL

A 18F-FET PET scan is performed

Diagnostic Test: 18F-FET PET

Interventions

18F-FET PET DIAGNOSTIC_TEST

Patient are investigated with an 18F-FET PET

All included patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspicion of newly diagnosed CNS tumor, recurrence or radiation therapy planning
• age \<18 years at first CT/MRI suggesting CNS tumor
• written informed consent from parents (age \< 18 years) or the patient (age \>18 years)

You may not qualify if:

• contraindications for MRI (e.g. metal implants)
• pregnancy
• known syndrome with increased sensitivity to radiation (e.g. Gorlin or Ataxia Telangiectasia

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Børnecancerfonden: collaborator

Study Sites (1)

Copenhagen University Hospital Rigshospitalet

Copenhagen, Copenhagen O, DK-2100, Denmark

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Lisbeth Marner, MD PhD DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisbeth Marner, MD PhD DMSc

CONTACT

0045 35450968; lisbeth.marner.01@regionh.dk

Ian Law, MD PhD DMSc

CONTACT

0045 35458513; ian.law@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The result of the PET scan is masked until a treatment plan for the patient has been decided by the treatment responsible clinicians based on the MRI findings.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DMSc, Staff Specialist

Model Details: We aim to include all patients that fullfil the inclusion criteria.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: January 18, 2018
• Study Start: February 24, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)