Value of FLT-PET Before and During Radiotherapy in Head a... | NCT00163176

Studies
Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors

NCT00163176

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Dec 16, 2011Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Head and Neck Neoplasms

Interventions

Not provided

Countries

Netherlands

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

Dec 2011

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

Jul 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 13, 2005Estimated

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

Dec 15, 2011

Last Update Posted Date

Dec 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Tumor cell proliferation and repopulation contribute to resistance to radiotherapy in head and neck cancer. Up to now, this characteristic is mostly assessed using biopsies acquired during inspection under general anaesthesia before treatment.

18F-FLT-PET (positron emission tomography) is a non-invasive imaging method showing areas of active proliferation. The aim of this study is to assess the value of the functional information gained by 18F-FLT-PET for radiotherapy planning and early tumor response assessment.

Prior to radiotherapy, a planning CT-scan and a 18F-FLT-PET scan are acquired. After approximately two weeks of radiotherapy a further PET scan is obtained.

Detailed Description

Not provided

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

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of 18F-FLT-PET-signal changes before and during therapy with treatment outcome (clinical response and local tumor control)		1 year

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the value of the functional information gained by 18F-FLT-PET regarding the definition of the planning target volume (PTV) for radiotherapy.		2 months
Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy.		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stage II - IV squamous cell carcinoma of the head-and-neck region, treated with radiotherapy or radiochemotherapy with curative intent.
18 years or older
Informed consent

Exclusion Criteria:

Patients who have undergone surgery as primary tumor therapy.
Patients treated with palliative intent.
Pregnancy

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

Stage II-IV squamous cell carcinoma of the head and neck

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johannes HA Kaanders, PhD	Radboud University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen, Department of Radiotherapy		Nijmegen	Gelderland	6500 HB	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D006965	Hyperplasia

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided