- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00887718
Positron Emission Tomography(PET) in Lymphoma Assessment
17. december 2012 opdateret af: University Health Network, Toronto
Positron Emission Tomography for Staging, and Treatment Assessment of Response in Lymphomas (the Pet-star Lymphoma Study)
This study examines the role of a diagnostic test called Positron Emission Tomography (PET) scanning in patients with malignant lymphoma.
The primary goal of this study is to find out how well PET scanning can detect malignant (cancerous) lymphoma, and how often this extra information will result in a change of stage of disease, or will result in a change in treatment management plans of patients with lymphoma.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
It is currently unknown whether modifying treatment based on FDG-PET results is appropriate.
However, clinicians are increasingly using the FDG-PET result, where obtained, in deciding management.
Consequently, it would be premature to mandate PET-based treatment modifications in this protocol.
Patients will be treated with existing protocols at the discretion of their treating oncologists, based on available information.
Oncologists will be surveyed as to whether FDG-PET scan results could have (or affect patient management, and the intervention will be recorded).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
103
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network, Princess Margaret Hospital
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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
Group A: Newly Diagnosed
Inclusion Criteria:
- Patients > 18 years of age.
- Confirmed diagnosis of HL or NHL (any histology).
- Any Ann Arbor stage.
- Pre-treatment staging including CT of head and neck, chest, abdomen and pelvis, where there is a minimum one equivocal finding on the scan, affecting the assignment of stage or IPI factor (i.e. stage III/IV vs. stage I/II, or a question of extranodal involvement by disease).
Group B: Response Assessment
Inclusion Criteria:
- Patients > 18 years of age.
- Confirmed diagnosis of HL or NHL (any histology).
- Any Ann Arbor stage.
- Pre-treatment staging including CT neck, chest, abdomen and pelvis. If alternate assessment of the neck done by clinical palpitation, ultrasound, or MRI is negative, CT neck is not mandatory.
- Post-treatment staging including CT of head and neck, chest, abdomen and pelvis, at 1 - 6 weeks post-therapy.
- Treated with anthracycline-based chemotherapy, with or without radiation therapy (based on the stage of the disease). For Stage III/IV patients, PET will be done following completion of primary chemotherapy. For stage I/II patients, PET will be done after combined modality therapy, or after chemotherapy alone if this was the primary intention of therapy.
- Patients with residual mass on CT following primary chemotherapy with either "unconfirmed" CR (>75% decrease in size) or PR (³50% decrease in size), based on International workshop criteria.
Exclusion Criteria: Response Assessment
- None Curative treatment Intent
- After initial therapy the response status is: complete response, stable disease, or progressive disease
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 |
---|---|
Eksperimentel: PET scan for lymphoma assessment
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18F-Fluorodeoxyglucose (FDG) injection
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine:the frequency in which the FDG-PET scan result will change the clinical management of the patient, and to record the intervention instituted within 3 months of the PET scan 2)early relapse rates for PET positive, and PET negative patients.
Tidsramme: 24 months
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24 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To:1) describe & quantify potential changes in clinical practice caused by the adoption of FDG-PET scanning 2)correlate FDG-PET scan findings with disease characteristics, traditional standard response criteria, biopsy results, & early clinical outcome.
Tidsramme: 24 months
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24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Richard Tsang, MD, University Health Network, Princess Margaret Hospital
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. august 2007
Primær færdiggørelse (Faktiske)
1. juni 2011
Studieafslutning (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først indsendt
23. april 2009
Først indsendt, der opfyldte QC-kriterier
23. april 2009
Først opslået (Skøn)
24. april 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2012
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UHN REB 07-0235-C
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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