Assessment of Hematopoietic Recovery Following Chemothera... | NCT00775957

Studies
Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma

NCT00775957

Sponsor

University of Oklahoma

Status

Terminated

Last Update Posted

Sep 28, 2010Estimated

Enrollment

35Estimated

Phase

Not provided

Conditions

Non-Hodgkin's Lymphoma

Interventions

FLT-PET scan
FDG-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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated by institutional review board

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Not provided

Completion Date

Not provided

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

Sep 27, 2010

Last Update Posted Date

Sep 28, 2010Estimated

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

A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the "gold standard" FDG-PET.

Detailed Description

The first primary objective reflects a necessary and preliminary requirement: to reproduce published results and validate the use of FLT-PET. In this study, 35 patients will be selected to undergoing imaging with both FLT and FDG PET.

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

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		FLT-PET Scan	Procedure: FLT-PET scan
2		FDG-PET Scan	Procedure: FDG-PET scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FLT-PET scan	Procedure	imaging scan	1
FDG-PET scan

Measure	Description	Time Frame
Staging and ReStaging scans		after hematopoetic recovery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Women must not be pregnant or breast feeding
Histologic diagnosis of non-Hodgkin's lymphoma (any stage)
Must undergo treatment with chemotherapy and/or radiotherapy

Exclusion Criteria:

May not have received previous therapy with radiopharmaceuticals
May not have received prior therapy with cytotoxic chemotherapy and/or monoclonal antibodies

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

Subjects diagnosed with lymphoma and are about to start treatment with chemotherapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

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
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided