FET-PET/MRI for Surgical Assessment of Pediatric Brain Tu... | NCT03451123

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

NCT03451123

Sponsor

University of Alabama at Birmingham

Status

Terminated

Last Update Posted

Dec 19, 2023Actual

Enrollment

1Actual

Phase

Early Phase 1

Conditions

Pediatric Brain Tumors

Interventions

FET PET/MRI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Apr 23, 2018Actual

Primary Completion Date

Aug 29, 2023Actual

Completion Date

Aug 29, 2023Actual

First Submitted Date

Feb 23, 2018

First Submission Date that Met QC Criteria

Feb 23, 2018

First Posted Date

Mar 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2023

Last Update Posted Date

Dec 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objectives of this study are:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
FET-PET/MRI	Experimental	O-(2-[F-18]FET)-L-tyrosine (FET) for brain PET/MRI	Drug: FET PET/MRI

Name	Type	Description	Arm Group Labels	Other Names
FET PET/MRI	Drug	FET PET/MRI scan before and after surgery	FET-PET/MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
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.
Patient must be 18 years of age or younger at the time of study enrollment.
Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
Patient must have a life expectancy greater than 8 weeks.
Patient must be able to undergo FET-PET/MRI without sedation.
Females with childbearing potential must have a negative urine β-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:

Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.
Patient must not have received radiation therapy within the past 6 months.
Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).
Patient must not be pregnant or breast feeding.
Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
Patients must not have a history of brain metastases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided