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Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging

11. juni 2014 opdateret af: Memorial Sloan Kettering Cancer Center

The purpose of this study is to see how the brain re-learns to control the tongue in speaking and swallowing when either portions of the tongue have been removed, or when the tongue has been treated with radiation, in order to treat cancer. We hope the results of this study will help us to improve healing for patients who are being treated for cancer of the tongue.

When patients with cancer of the tongue are treated by removing parts of the tongue (surgery) or by destroying the cancer with radiation to the tongue, they have significant difficulty speaking and swallowing after such treatments. At this time, patients who have been treated for cancer of the tongue re-learn speaking and swallowing through exercises taught by a speech pathologist.

What is needed is information on how the brain re-learns to control speaking and swallowing so that we can help these patients re-learn faster after their treatments.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this investigation is to determine cortical mechanisms of adaptation to surgical or radiation treatment to the tongue. This study will use a non-invasive imaging technique, Functional Magnetic Resonance Imaging (fMRI), to investigate cortical responses to partial glossectomy or radiation therapy for treatment of a tongue malignancy. Patients with Stage I-IV (AJCC) malignancies of the tongue who are treated with surgery and or radiation therapy will be imaged using fMRI pre-operatively and at approximately six months postoperatively.

Patterns of brain activity from the fMRI studies will be compared with matched healthy control subjects. The results of this investigation will provide needed information on both central and peripheral mechanisms of adaptation.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

99

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Inclusion criteria for the tongue carcinoma patients:

  • Primary malignancy of the oral or base of tongue, Stage I-IV of AJCC staging system, planned for surgical or radiation therapy.

Inclusion criteria for the healthy subjects:

  • Healthy adult subjects between the ages of 21-75 years.

Exclusion Criteria:

Exclusion criteria for the tongue carcinoma patients include the following:

  • History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),
  • History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease.
  • History of previous moderate to severe traumatic brain injury.
  • History of significant cardiovascular, respiratory, gastrointestinal or renal disease (e.g.myocardial infarction within the previous 12 months, significant vaso-occlusive disease,severe or advanced asthma, COPD, emphysema, gastroesophageal reflux disease, or renal compromise)
  • History of achalasia
  • History of other neoplasms involving the brain, head and neck, or gastrointestinal system.
  • History of dysphagia, odynophagia, or aphasia unrelated to present illness.
  • History of significant claustrophobic reactions.
  • Standard contraindications to MR examinations (e.g. implanted stimulators).

Exclusion criteria for the healthy subjects includes the all of the conditions listed for the tongue:

  • Carcinoma patients and additionally includes history of significant surgery or previous radiation therapy to the head and neck
  • Previous history of dysphagia, odynophagia, aphasia, pregnancy,and standard contraindications to MR examinations.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Procedure: MRI
Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To utilize fMRI to characterize adaptation to alterations in tongue morphology & function following either surgical therapy, or radiation/chemotherapy to tongue in patients undergoing treatment of malignancies involving the tongue.
Tidsramme: 7 years
7 years

Sekundære resultatmål

Resultatmål
Tidsramme
Determine relationship between mechanisms of adaptation at level of central nervous system to alterations in function in the tongue.
Tidsramme: 7 years
7 years
Determine changes in cortical activity in representation of tongue movement that occur pre and post-treatment.
Tidsramme: 7 years
7 years
Determine the central neural response to direct peripheral rehabilitation strategies.
Tidsramme: conclusion of study
conclusion of study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Memorial Sloan Kettering Cancer Center

Samarbejdspartnere

New York Presbyterian Hospital
Rockefeller University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2002

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

7. januar 2008

Først indsendt, der opfyldte QC-kriterier

15. januar 2008

Først opslået (Skøn)

16. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 02-093

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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