MRI in Finding Hypoxia in Patients Undergoing Chemo and R... | NCT00896350

Studies
MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer

NCT00896350

Sponsor

University of Texas Southwestern Medical Center

Status

Terminated

Last Update Posted

Feb 18, 2019Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Head and Neck Cancer

Interventions

Standard Care Chemoradiation

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

ID	Type	Description	Link
CDR0000637640	Registry Identifier	PDQ (Physician Data Query)
NCI-2011-02811	Registry Identifier	CTRP (Clinical Trials Reporting System)

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2009Actual

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

May 8, 2009

First Submission Date that Met QC Criteria

May 8, 2009

First Posted Date

May 11, 2009Estimated

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

Feb 14, 2019

Last Update Posted Date

Feb 18, 2019Actual

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

RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment.

PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.

Detailed Description

OBJECTIVES:

Determine the undertaken oxygen sensitive MRI for the detection of hypoxia in patients with Stage III-IV head and neck cancer.
Correlate MRI parameters with histology, gene expression, and plasma osteopontin.
Correlate tumor hypoxia measurements with patient prognosis and treatment response.

OUTLINE:

Pre-therapy MRI: Patients undergo blood oxygen level dependant (BOLD) contrast MRI on room air breathing over 2 minutes and with oxygen gas over 15 minutes. Patients also undergo MR-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast MRI with gadolinium contrast over 8 minutes.
Chemoradiotherapy: Patients receive platinum based chemotherapy every two weeks. Patients also undergo radiation therapy for 6 weeks.
Post-radiation MRI: Patients undergo MRI as before chemoradiotherapy. Blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response.

After completion of study, patients are followed every 3 months for up to 1 year.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BOLD MRI	Experimental	Determine the amount of oxygen supply to tumors.	Drug: Standard Care Chemoradiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Care Chemoradiation	Drug	External beam radiation to the neck and tumor site of head and neck. Concurrent platinum based chemotherapy. External beam "boost" at discretion of treating physician.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRI signal sensitivity to oxygen	MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)	12 weeks
Tumor shrinkage and blood oxygen association	Association between tumor shrinkage and blood oxygen level dependent	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Correlate tumor hypoxia with patient prognosis and treatment response	Association between tumor hypoxia, patient prognosis, and treatment response.	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the head and neck
- Stage III or IV disease
Measurable disease
Scheduled to undergo standard treatment including radiation therapy and chemotherapy
Participation on study # 092004-010 for tissue procurement

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Serum creatinine ≤ 1.5 OR creatinine clearance ≥ 40
Body mass index ≤ 34 Kg/m^2
Not claustrophobic
No other contraindications to MRI (i.e., implanted pacemaker device)
Not pregnant or nursing
Negative pregnancy test
No allergy to gadolinium

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Baran Sumer, MD	Simmons Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas		Dallas	Texas	75390	United States

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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