Metabolic Tumor Volumes in Radiation Treatment of Primary... | NCT02006563

Studies
Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors

NCT02006563

Sponsor

University of Miami

Status

Completed

Last Update Posted

Oct 24, 2017Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Brain Tumor
Glioblastoma Multiforme

Interventions

Not provided

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2011Actual

Primary Completion Date

Jan 2016Actual

Completion Date

Jul 2017Actual

First Submitted Date

Dec 4, 2013

First Submission Date that Met QC Criteria

Dec 4, 2013

First Posted Date

Dec 10, 2013Estimated

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

Oct 20, 2017

Last Update Posted Date

Oct 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

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

Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.

Detailed Description

Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.

If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors	To evaluate the extent to which tumor volumes, determined by spectroscopic imaging (MTV) differ from the traditionally prescribed clinical treatment volumes (CTV) for radiation therapy	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must have histologically confirmed primary brain tumor.
Patients may be enrolled prior to surgery, after surgical resection or with unresectable tumors.
Patients must be 18 years or older.
Patients who do not have metal in the body (e.g. pacemakers, implants) that would preclude them from undergoing MRI/MRS exam
Patients who do not suffer from claustrophobia (fear of enclosed spaces)
Karnofsky performance status ≥ 60.
Patients whose size would allow them to fit into the bore of the MRI instrument.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients younger than 18 years.
Inability to undergo MRI/MRS exam because of metal in the head or body, such as implants, pacemaker, or biostimulation device. Claustrophobia (fear of enclosed spaces).
Karnofsky performance status < 60.
Patients too large (> 300 lbs.) to fit into the bore of the MRI instrument.
Inability to understand the informed consent document.

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

It is estimated that approximately 39% of the patients with primary brain tumors, seen in the Department of Radiation Oncology, Sylvester Cancer Center are women. Further, it is estimated that 58% of patients are White, 6% are African American, 36% are Hispanic and 0% are other based upon standard NIH definitions.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Radka Stoyanova, PhD	University of Miami	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D005909	Glioblastoma

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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