Positron Emission Tomography in Detecting Testicle Cancer
A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor
RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer.
PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of the testicle.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Assess the ability of fludeoxyglucose F 18 positron emission tomography to predict relapse requiring adjuvant chemotherapy in patients with high-risk stage I non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis who are on current management protocols.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 1 hour later by positron emission tomography (PET) imaging. Patients with metastatic disease identified by FDG PET imaging may receive adjuvant chemotherapy according to the standard clinical practice at each participating center. Patients with no metastatic disease identified by FDG PET imaging are considered for entry into the MRC-TE08 trial (randomized trial of 2 CT scan frequencies in the surveillance of stage I teratoma) or are followed according to the standard surveillance schedule.
Patients with metastatic disease are followed every 6 months. Patients with no metastatic disease are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 4-6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 135 patients will be accrued for this study within 2-3 years.
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
England
-
Exeter, England, Det Forenede Kongerige, EX2 5DW
- Royal Devon and Exeter Hospital
-
Ipswich, England, Det Forenede Kongerige, IP4 5PD
- Ipswich Hospital NHS Trust
-
London, England, Det Forenede Kongerige, SE1 9RT
- Guy's and St. Thomas' Hospitals NHS Foundation Trust
-
London, England, Det Forenede Kongerige, WIT 3AA
- Meyerstein Institute of Oncology at University College of London Hospitals
-
Nottingham, England, Det Forenede Kongerige, NG5 1PB
- Nottingham City Hospital NHS Trust
-
Southampton, England, Det Forenede Kongerige, 5O14OYG
- Royal South Hants Hospital
-
Sutton, England, Det Forenede Kongerige, SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
-
-
Scotland
-
Glasgow, Scotland, Det Forenede Kongerige, G11 6NT
- Beatson Oncology Centre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis with evidence of vascular (lymphatic or venous) invasion in primary specimen
- Clinical stage I on the basis of clinical examination, chest x-ray, and CT scan of the chest, abdomen, and pelvis
- Negative post-orchidectomy tumor markers (alpha-fetoprotein and beta human chorionic gonadotropin)
- High-risk disease
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No evidence of active inflammatory or infective diseases
- No other disease or prior malignancy that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- No more than 8 weeks since prior orchidectomy
Other
- No prior positron emission tomography scans
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Robert A. Huddart, MD, Royal Marsden NHS Foundation Trust
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- testikel teratom
- testikel embryonalt karcinom
- testikel choriocarcinom
- testikelblommesæk tumor
- testikel embryonal karcinom og teratom
- testikel embryonalt karcinom og teratom med seminom
- testikel embryonal carcinom og blommesæk tumor
- testikel embryonal carcinom og blommesæk tumor med seminom
- testikel embryonal karcinom og seminom
- testikelblommesæktumor og teratom
- testikelblommesæktumor og teratom med seminom
- testikel choriocarcinom og blommesæk tumor
- testikel choriocarcinom og embryonal carcinom
- testikel choriocarcinom og teratom
- testikel choriocarcinom og seminom
- stadium I malign testikel-kimcelletumor
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000256314
- MRC-TE22
- EU-20115
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 .