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FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer (ACRIN6685)

22. oktober 2020 opdateret af: American College of Radiology Imaging Network

A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors find head and neck cancer and find out how far the disease has spread. It may also help doctors plan the best treatment.

PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the negative predictive value of PET/CT imaging based upon pathologic sampling of the neck lymph nodes in patients with head and neck cancer planning to undergo N0 neck surgery.
  • Determine the potential of PET/CT imaging to change treatment.

Secondary

  • Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local sites.
  • Determine the effect of other factors (e.g., tumor size, location, secondary primary tumors, or intensity of FDG uptake) that can lead to identification of subsets of patients that could potentially forego neck dissection or that can provide preliminary data for subsequent studies.
  • Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer vs current good clinical practices.
  • Evaluate the incidence of occult distant body metastasis discovered by whole-body PET/CT imaging.
  • Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
  • Evaluate the quality of life of these patients, particularly of those patients whose management could have been altered by imaging results.
  • Evaluate PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction.
  • Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence, disease-free survival, and overall survival.
  • Determine the proportion of neck dissections that are extended (i.e., additional levels that clinicians intend to dissect beyond the initial surgery plan) based on local-reader PET/CT imaging findings shared with the surgeon before dissection.
  • Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging.
  • Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location).

OUTLINE: This is a multicenter study.

Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients undergo unilateral or bilateral neck dissection.

Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months after surgery.

Patients undergo blood and tissue sample collection periodically for biomarker analysis.

Patients are followed up periodically for up to 2 years after surgery.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

292

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
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Los Angeles, California, Forenede Stater, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Florida
      • Safety Harbor, Florida, Forenede Stater, 34695
        • Morton Plant Mease Cancer Care at Mease Countryside Hospital
      • Tampa, Florida, Forenede Stater, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40245
        • Jewish Hospital Heart and Lung Institute
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Kina
      • Beijing, Kina, 100730
        • Peking Union Medical College Hospital

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed squamous cell carcinoma (SCC) of the head and neck , including any of the following sites:

    • Oral cavity
    • Oropharynx, including base of tongue and tonsils
    • Larynx
    • Supraglottis

  • Stage T2-T4, N0-N3 disease

    • Unilateral or bilateral neck dissection planned

      • No N2c disease (if bilateral disease is present)

    • Has ≥ 1 clinically N0 neck side as defined by clinical exam (physical exam with CT scan and/or MRI)

      • A N0 neck must be planned to be dissected for the patient to be eligible
      • . The N0 neck can be either ipsilateral to the head and neck tumor or the contralateral N0 neck if a bilateral neck dissection is planned

  • CT scan and/or MRI taken within the past 4 weeks to confirm SCC of the head and neck

    • Simultaneous diagnostic CT with PET scan allowed; however, PET cannot be used as part of the criteria to define the N0 neck disease
    • For CT scan and/or MR images from other institutions, ACRIN recommends a re-read by a local neuro-radiologist to ensure compliance
  • No sinonasal cancer, salivary gland cancer, thyroid cancer, nasopharyngeal cancer, or advanced skin cancer

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Weight ≤ 350 lbs
  • No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications (optimally, patients will have glucose < 150 mg/dL)
  • No underlying medical condition that would preclude surgery (neck dissection)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

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: FDG PET/CT
Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol.
Procedure: terapeutisk konventionel kirurgi
Stråling: fludeoxyglucose F 18

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
Tidsramme: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
True negative cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise.
Within Two Weeks Before Surgery and after sampling of neck lymph nodes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinically N0 neck (both by neck and lymph node regions) or other local sites
Tidsramme: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
True positive cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise. The diagnostic yield is defined as the ratio of cancers to total screened
Within Two Weeks Before Surgery and after sampling of neck lymph nodes
Determine which factors (e.g., tumor size, secondary primary tumors, location, or intensity of FDG uptake) may identify patients who can forego neck dissection
Tidsramme: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
True positive cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise. The diagnostic yield is defined as the ratio of cancers to total screened
Within Two Weeks Before Surgery and after sampling of neck lymph nodes
Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices
Tidsramme: 2 years post-surgery
The outcome measure will use the total cost of care for each participant to compute the incremental cost-effectiveness ratio (ICER)
2 years post-surgery
Incidence of occult distant body metastasis discovered by whole body PET/CT imaging
Tidsramme: Within Two Weeks Before Surgery
this outcome will count the distant body metastasis not previously seen and report the results as a percentage.
Within Two Weeks Before Surgery
Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results
Tidsramme: Within Two Weeks Before Surgery
the outcome measure will consist of paired proportions of dichotomized PET/CT and CT/MRI test results; and biomarker test results
Within Two Weeks Before Surgery
Quality of life (QOL), particularly in patients whose management could have been altered by imaging results
Tidsramme: 2 years post-surgery
QOL will be assessed using SF-36, Non-Utility HUI, and UW-QoL scores
2 years post-surgery
Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction
Tidsramme: Within Two Weeks Before Surgery
the metastatic disease status is the response variable and PET/CT test results and biomarker data are predictors.
Within Two Weeks Before Surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence
Tidsramme: 2 years post-surgery
model the associations of PET/CT test results and biomarker data (predictors) to recurrence
2 years post-surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of disease-free survival
Tidsramme: 2 years post-surgery
model the associations of PET/CT test results and biomarker data (predictors) to disease-free survival
2 years post-surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of overall survival
Tidsramme: 2 years post-surgery
model the associations of PET/CT test results and biomarker data (predictors) to overall survival (censored responses)
2 years post-surgery
Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection
Tidsramme: Within Two Weeks Before Surgery
Outcome is defined as the number patients who surgeons intend to dissect levels beyond the initial surgery plan
Within Two Weeks Before Surgery
Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging
Tidsramme: Within Two Weeks Before Surgery
ROC analysis will be used to maximize the youden index and estimate the optimum cutoff value of SUV for diagnostic accuracy of PET/CT on N0 neck
Within Two Weeks Before Surgery
Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location)
Tidsramme: Within Two Weeks Before Surgery
Diagnostic Accuracy measures will be calculated using ROC analysis, subset by anatomic location
Within Two Weeks Before Surgery

Samarbejdspartnere og efterforskere

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

Sponsor

American College of Radiology Imaging Network

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Val J. Lowe, MD, Mayo Clinic

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.

Generelle publikationer

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 (Faktiske)

1. april 2010

Primær færdiggørelse (Faktiske)

15. januar 2019

Studieafslutning (Forventet)

1. december 2021

Datoer for studieregistrering

Først indsendt

23. september 2009

Først indsendt, der opfyldte QC-kriterier

23. september 2009

Først opslået (Skøn)

24. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000654703
  • U01CA080098 (U.S. NIH-bevilling/kontrakt)
  • U01CA079778 (U.S. NIH-bevilling/kontrakt)
  • ACRIN-6685 (Anden identifikator: CIP ID)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

See ACRIN data sharing policy:

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

IPD-delingstidsramme

by request 6+ mo after publication available through The Cancer Imaging Archive expected 1-year after publication.

IPD-delingsadgangskriterier

Safe-Harbor deidentified data

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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