NCT01254591

Brief Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease. PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

August 26, 2013

Status Verified

December 1, 2010

Enrollment Period

6.8 years

First QC Date

December 3, 2010

Last Update Submit

August 23, 2013

Conditions

Breast CancerColorectal CancerEsophageal CancerHead and Neck CancerLung Cancer

Keywords

stage IA non-small cell lung cancerstage IB non-small cell lung cancerstage IIA non-small cell lung cancerstage IIB non-small cell lung cancerstage IIIA non-small cell lung cancerstage I colon cancerstage IIA colon cancerstage IIB colon cancerstage IIC colon cancerstage IIIA colon cancerstage I rectal cancerstage IIA rectal cancerstage IIB rectal cancerstage IIC rectal cancerstage IIIA rectal cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage I esophageal cancerstage II esophageal cancerstage III esophageal cancerstage I hypopharyngeal cancerstage II hypopharyngeal cancerstage III hypopharyngeal cancerstage I laryngeal cancerstage II laryngeal cancerstage III laryngeal cancerstage I lip and oral cavity cancerstage II lip and oral cavity cancerstage III lip and oral cavity cancerstage I nasopharyngeal cancerstage II nasopharyngeal cancerstage III nasopharyngeal cancerstage I oropharyngeal cancerstage II oropharyngeal cancerstage III oropharyngeal cancerstage I paranasal sinus and nasal cavity cancerstage II paranasal sinus and nasal cavity cancerstage III paranasal sinus and nasal cavity cancerstage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancertongue cancer

Outcome Measures

Primary Outcomes (2)

  • Clinical, radiological, and pathological correlation

  • Prognosis (6-month, 1-year, 3-year, and 5-year mortality including local/distance recurrence rates)

Interventions

18F-fluoromisonidazoleOTHER
fluorescence angiographyOTHER
laboratory biomarker analysisOTHER
infrared thermographyPROCEDURE
magnetic resonance imagingPROCEDURE
therapeutic conventional surgeryPROCEDURE
[18F]-ML-10RADIATION
fludeoxyglucose F 18RADIATION
rubidium Rb-82RADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer * Potentially operable disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Not specified * Menopausal status not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University College Hospital

London, England, NW1 2BU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsHead and Neck NeoplasmsLung NeoplasmsCarcinoma, Non-Small-Cell LungColonic NeoplasmsRectal NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsMouth NeoplasmsNasopharyngeal NeoplasmsOropharyngeal NeoplasmsSalivary Gland NeoplasmsTongue Neoplasms

Interventions

fluoromisonidazoleMagnetic Resonance Spectroscopy5-fluoropentyl-2-methylmalonic acidFluorodeoxyglucose F18Rubidium-82

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEsophageal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesMouth DiseasesNasopharyngeal DiseasesSalivary Gland DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Peter Ell, MD

    University College London Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 6, 2010

Study Start

November 1, 2006

Primary Completion

August 1, 2013

Last Updated

August 26, 2013

Record last verified: 2010-12

Locations

GB(1)