FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors

Pediatric Brain Tumors Clinical Trial

Official title:

FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03451123
• Other study ID #: R17-077
• Status: Terminated
• Phase: Early Phase 1
• Start date: April 23, 2018
• Est. completion date: August 29, 2023

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are:

1. Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone.

2. Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI.

A secondary objective of this study is:

1) Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Patient must have a known or suspected primary brain tumor with a non-enhancing component with planned standard of care surgical resection. Patients with newly diagnosed or recurrent brain tumors are eligible.

2. Tumors with non-enhancing regions will be defined as T2/FLAIR hyperintensity extending at least 0.5 cm beyond areas of enhancement as assessed by MRI.

3. Patient must be 18 years of age or younger at the time of study enrollment.

4. Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.

5. Patient must have a life expectancy greater than 8 weeks.

6. Patient must be able to undergo FET-PET/MRI without sedation.

7. Females with childbearing potential must have a negative urine ß-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration FET. Females who have not reached menarche will not require pregnancy testing.

Exclusion Criteria:

1. Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.

2. Patient must not have received radiation therapy within the past 6 months.

3. Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).

4. Patient must not be pregnant or breast feeding.

5. Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.

6. Patients must not have a history of brain metastases.

Related Conditions & MeSH terms

• Brain Neoplasms
• Pediatric Brain Tumors

Intervention

Drug:
• FET PET/MRI
FET PET/MRI scan before and after surgery

Locations

Country	Name	City	State
United States	UAB Advanced Imaging Facility	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients whose surgical plan change with FET-PET/MRI compared to MRI alone.	Surgical planning will be performed prior to brain tumor resection based on MRI alone and then with FET-PET/MRI. The surgical margins will be compared and the percentage of patients whose surgical plans change with FET-PET/MRI will be calculated.	2 years
Primary	Percentage of patients who have residual tumor after surgery detected with FET-PET/MRI	The percentage of patients with residual tumor identified with FET-PET/MRI will be measured. This percentage will be compared to detection of residual tumor by MRI alone.	2 years