Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
20. juni 2012 opdateret af: Ontario Clinical Oncology Group (OCOG)
A Prospective Cohort Study to Determine the Sensitivity of Positron Emission Tomography (PET) in Detecting Metastatic Cancer in Neck Lymph Nodes in Patients With Squamous Cell Head & Neck Cancer Managed With Primary Radiation Therapy
The purpose of this trial is to determine the ability of positron emission tomography (PET) to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy for squamous cell cancer arising in the head and neck.
Patients with head and neck cancer (HNC) undergo treatment of curative intent; patients who are node positive (N2 N3 stages) undergo standard management which includes post-radiation planned neck dissection but two thirds of patients end up not having evidence of residual disease in neck dissection specimens; these patients could have avoided surgery. However, currently used standard tests, like computed tomography (CT) and/or magnetic resonance imaging (MRI) cannot reliably predict who is post-radiation disease free.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PET-Fluorodeoxyglucose scanning is an imaging test based on the increased uptake of radiolabelled glucose by tumour cells.
PET might detect neck tumours better than other imaging tests.
This is a cohort study in which patients with N2 N3 squamous cell carcinoma of the head and neck undergo a PET and a CT scan at baseline and then post-radiation therapy and chemotherapy.
Then, they undergo neck dissection surgery.
The PET and CT results are compared with the presence or absence of tumours in the neck nodes.
If PET is sufficiently accurate in predicting the presence or absence of tumours in the neck nodes, then a neck dissection could be avoided.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
400
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
-
London, Ontario, Canada, N6A 4L6
- London Regional Cancer Centre
-
Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret 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
Inclusion Criteria:
All of the following criteria must be satisfied:
- Histological evidence of squamous cell carcinoma of the head & neck (T1-T4 arising in either the oral cavity, larynx & pharynx, except Nasopharyngeal carcinoma);OR patients with histological evidence of squamous cell carcinoma metastatic to the neck and an unknown primary site after conventional workup without any of the following: i). Clinically suspected skin primary or previous diagnosis of skin cancer arising in the head and neck area; ii). Patients of Asian or African decent -possible nasopharynx primary; iii). Patients whose malignant adenopathy is confined to zone V -possible nasopharynx primary; and iv). Patients whose malignant adenopathy is confined to zone IV (supraclavicular)-possible lung primary.
- Presence of advanced N2 or N3 neck disease.
- Planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment.
Exclusion Criteria:
- Presence of distant metastasis
- Recurrent tumour
- Prior neo-adjuvant chemotherapy
- Previous radiation therapy to intended treatment volumes
- Other active malignancy
- Surgically inoperable neck disease
- Unable to remain supine for 60 minutes
- Unfit to undergo general anesthetic or neck dissection for medical reasons
- Known hypersensitivity to CT contrast
- Pregnancy
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: PET
All patients receive PET scan and conventional CT imaging.
|
PET scans, Pre and post radiation treatment
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ability of PET compared to CT in identifying the presence of tumour in neck nodes
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tumour at the primary site 8-10 weeks following radiation;
Tidsramme: 2 years
|
2 years
|
|
The change in PET signal (standard uptake value;
Tidsramme: 2 years
|
2 years
|
|
Local recurrence, distant metastases and survival
Tidsramme: 2 years
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark N Levine, MD, Ontario Clinical Oncology Group (OCOG)
- Studiestol: John Waldron, MD, Princess Margaret Hospital, Canada
- Ledende efterforsker: Ralph Gilbert, MD, Princess Margaret Hospital, Canada
- Ledende efterforsker: Libni Eapen, MD, Ottawa Regional Cancer Centre
- Ledende efterforsker: Anne Keller, MD, Princess Margaret Hospital, Canada
- Ledende efterforsker: Bayardo Perez-Ordonez, MD, Princess Margaret Hospital, Canada
- Ledende efterforsker: Chu-Shu Gu, M.Sc., Ontario Clinical Oncology Group (OCOG)
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. maj 2004
Primær færdiggørelse (Faktiske)
1. august 2009
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
1. september 2005
Først indsendt, der opfyldte QC-kriterier
6. september 2005
Først opslået (Skøn)
7. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. juni 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juni 2012
Sidst verificeret
1. juni 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CTA-Control-088421
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