Assessment of Suspected Intracranial Malignancy Using 3'-... | NCT00775320

Studies
Assessment of Suspected Intracranial Malignancy Using 3'-Deoxy-3'18 F-flourothymidine PET

NCT00775320

Sponsor

University of Oklahoma

Status

Terminated

Last Update Posted

Nov 25, 2019Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Brain Tumor

Interventions

FLT-PET scan

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study closed by institutional review board

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Oct 17, 2008

First Submission Date that Met QC Criteria

Oct 17, 2008

First Posted Date

Oct 20, 2008Estimated

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

Nov 20, 2019

Last Update Posted Date

Nov 25, 2019Actual

Name	Class
Midwest Medical Isotopes	UNKNOWN

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

The primary objective of this study is to detect and quantify tumor cells of high grade malignant gliomas and metastatic brain lesions both before and after initial surgical resection in a cohort of newly diagnosed patients.

Detailed Description

In this study, 35 patients will be selected to undergoing sequential imaging with FLT-PET. Prior to surgical resection, patients will undergo a preliminary FLT-PET. Additional FLT scans for a maximum of four scans.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brain tumor FLT-PET		Those diagnosed with a brain tumor and are to undergo surgery	Procedure: FLT-PET scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FLT-PET scan	Procedure	Imaging test	Brain tumor FLT-PET

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Women must not be pregnant or breast feeding
Histologic or strong radiologic suspicion of high grade malignant glioma or ogliometastatic tumor(s)

Exclusion Criteria:

May not have received previous therapy for their malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects diagnosed with a brain tumor and to undergo surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Holter, MD	Assistant Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Of Oklahoma Health Sciences Center		Oklahoma City	Oklahoma	73104	United States

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

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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