Evaluating Tumor Pseudoprogression With FLT-PET and MRI | NCT01105988

Studies
Evaluating Tumor Pseudoprogression With FLT-PET and MRI

NCT01105988

Sponsor

Massachusetts General Hospital

Status

Terminated

Last Update Posted

Jan 6, 2012Estimated

Enrollment

2Actual

Phase

Early Phase 1

Conditions

Glioblastoma

Interventions

Radiologic exams

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding ended

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Apr 15, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 19, 2010Estimated

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

Jan 4, 2012

Last Update Posted Date

Jan 6, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth R. Gerstner, MD, Principal Investigator, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Dana-Farber Cancer Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A standard treatment for glioblastoma is a combination of radiation and the drug temozolomide. This combination sometimes causing swelling (inflammation) of the brain tissue. When standard monitoring with MRI or CT scans is done within a few months of finishing treatment, it may be hard to tell if the scans are showing post-treatment brain inflammation or tumor growth and worsening of disease. Currently the only way to definitively distinguish inflammation from tumor growth is biopsy.

However, biopsy is an invasive procedure that is associated with risks. Having a non-invasive method to distinguish post-treatment inflammation from tumor growth can help improve care for patients with glioma.

For the PET scans in this research study, the investigators are using a radioactive substance called FLT (3'-deoxy-3'-[F-18] fluorothymidine), instead of the standard substance FDG (fluorodeoxyglucose). FLT gets absorbed by cancer cells but not by areas of inflammation. Because of that FLT may be better than FDG in differentiating cancer cells from inflammation.

An MRI scan will also be done at the same time as each of the 2 FLT-PET scans done for this research study. The two MRI scans performed will also help give more information about the patient's tumor that is not routinely provided with a routine clinical scan, such as blood flow through the tumor or metabolic activity in the tumor. The information from these special MRI scans may provide more information about the blood supply to the tumor and how this changes in response to treatment. In addition, the MRI scans along with the FLT-PET scans may help how to distinguish inflammation due to radiation therapy from tumor growth.

Detailed Description

If you are eligible to participate in this study you will have a pre-treatment FLT-PET scan within 7 days before starting treatment with radiation and temozolomide.

Two intravenous catheters (IVs) will be placed for each scan. One IV will be used to inject the FLT for the PET scan and the contrast agent for the MRI scan. The second IV will be used to draw blood for research tests. The PET scan will take about 2 hours. The MRI scan will take about 60-75 minutes. They will be done simultaneously.

About 4 weeks after you finish radiation therapy you will have a second FLT-PET scan and MRI scan.

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

2Actual

Name	Type	Description	Arm Group Labels	Other Names
Radiologic exams	Other	FLT PET scan x 2 MRI scan x 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Outcome Measure	To determine if elevated FLT PET uptake 4 weeks after completion of chemoradiation is associated with early tumor growth rather than treatment effect in patients with newly diagnosed glioblastome treated with standard chemoradiation.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Secondary Outcome Measure	To clarify the impact of radiation and temozolomide chemotherapy on tumor cell proliferation.	2 years
Secondary Outcome Measure	To compare blood-derived kinetic parameters of tumor cell proliferation rate with image derived parameters of proliferation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed newly diagnosed glioblastoma
Planned treatment for glioblastoma is standard radiation and temozolomide
Measurable disease
Life expectancy >/= 12 weeks
Lab values must be within limits specified in protocol
Able to undergo MRI and PET scans
On stable dose of steroids for 5 days prior to each MRI scan

Exclusion Criteria:

Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or not recovered from adverse events from prior therapy
Receiving any other study agents to treat tumor
History of allergic reactions to compounds of similar chemical or biologic composition to FLT
Uncontrolled intercurrent illness
Pregnant or nursing
HIV-positive

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth Gerstner, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

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Browse Branches

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