FLT-PET Imaging of Brain Tumors in Children

NCT01244737 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IND 104365R01FD003718
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-\[F-18\] fluorothymidine (18F-FLT) in the medical management of brain tumors in children. Funding source - FDA Office of Orphan Product Development (OOPD)

Conditions

Brain Neoplasms

Keywords

Brain neoplasms; Children; Positron-Emission Tomography; 18F-FLT

Outcome Measures

Primary Outcomes (2)

• [18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation

  \[18F\] FLT uptake, as determined by pre-operative positron emission tomography (PET) imaging, will be compared to histological markers of cellular proliferation in the resected brain tumor. This will be performed in three groups of subjects (3 arms): (1)children with newly diagnosed central nervous system tumors, (2) children in whom there is concern for recurrence of central nervous system tumor,(3) children with central nervous system tumors that are treated with post-operative chemotherapy.

  on average 1 week

• MIB Positive (Percent)

  On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining

  30 days

Secondary Outcomes (2)

• Biodistribution of [18F]FLT

  6 hours

• Preliminary Evaluation of Clinical Utility of [18F] FLT PET

  3 months

Study Arms (3)

New diagnosis of brain tumor

EXPERIMENTAL

In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT.

Drug: [18F] FLT

Possible recurrent brain tumor

EXPERIMENTAL

In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET.

Drug: [18F] FLT

Brain tumor response to chemotherapy

EXPERIMENTAL

In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment.

Drug: [18F] FLT

Interventions

[18F] FLT DRUG

\[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan

Also known as: 3'-deoxy-3'-[F-18] fluorothymidine, [18F] fluorothymidine

Brain tumor response to chemotherapy; New diagnosis of brain tumor; Possible recurrent brain tumor

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 21 years or less
• capable of achieving imaging without need for sedation or anesthesia (typically age 8 years or greater, but there is no lower limit for age for eligibility)
• Karnofsky Performance Status of 50 or greater in subjects age 12 years or greater, for age less than 12 years a Lansky play scale of 50% or greater
• Patients receiving steroids and/or anti-seizure medications are eligible

You may not qualify if:

• clinically active infection
• pregnancy or breast-feeding
• serious intercurrent medical illness
• require emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging

Sponsors & Collaborators

• Frederick Daniel Grant: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

alovudine

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Arm 3: Despite much recruitment effort, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment.

Results Point of Contact

• Title: Dr. Frederick Grant
• Organization: Children's Hospital of Philadelphia

grantf@chop.edu

267-600-1542

Study Officials

• Frederick D Grant, MD

  Children's Hospital, Boston, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Radiology

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 19, 2010
• Study Start: October 1, 2010
• Primary Completion: February 5, 2023
• Study Completion: February 5, 2023
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)