- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01999998
FDG PET-CT for Lymphoma Radiotherapy Planning Version 1.3
A Pilot Study to Optimise the Use of FDG PET-CT and Deformable Image Co-registration for Lymphoma Radiotherapy Planning
Chemotherapy followed by radiotherapy is used to treat early stage lymphomas with excellent cure rates. However, a significant proportion of these patients develop cancers and heart diseases years later as a result of the radiotherapy. Therefore, there is a move to reduce radiation exposure without compromising cure rates. Radiotherapy is planned using a CT scan taken following chemotherapy when many of the original sites of the lymphoma are no longer visible using a CT scan taken following chemotherapy when many of the original sites of the lymphoma are no longer visible.
In order to safely minimise the volume treated with radiotherapy it is necessary to accurately reconstruct the extent of the lymphoma prior to chemotherapy on this 'planning' CT scan. A PETCT prior to chemotherapy is the best way of demonstrating the original extent of the lymphoma, but is taken in a different position to the radiotherapy treatment position. This aim of this study is to explore whether a PETCT scan taken prior to chemotherapy in the radiotherapy treatment position, in conjunction with advanced software to combine this scan with the subsequent radiotherapy planning CT, can be used to more accurately identify the lymphoma target. The study aims to recruit up to 20 patients with early stage Hodgkin lymphoma or high grade nonHodgkin lymphoma. A routine staging PETCT will be followed at the same session by a PETCT in the radiotherapy treatment position appropriate radiotherapy immobilisation devices. Participation in the study will not affect treatment decisions or the radiotherapy planning process. The PETCT in the radiotherapy planning position will be made available to the treating clinicians. The process of planning radiotherapy will not be systematically altered by the study. The study is aimed at determining how to improve the radiotherapy planning process in the future, in the hope of a reducing in the long term side effects of treatment whilst retaining high cure rates.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Leeds, Regno Unito, LS9 7TF
- Reclutamento
- The Leeds Teaching Hospitals Nhs Trust
-
Contatto:
- Robin Prestwich, PhD, FRCR, MRCP, BMBCh
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age ≥18
- WHO Performance status 02
- Histologically proven Hodgkin lymphoma or high grade nonHodgkin lymphoma
- Ann Arbor Stage I/II disease based upon clinical examination and any radiology investigations performed
- Clinical decision to proceed with sequential chemotherapy and radiotherapy if stage I/II disease is confirmed on subsequent 18FDGPETCT staging
- Residual disease in situ after biopsy
- Able to provide fully informed written consent
- Able to lie flat for 1 hour
- Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.
Exclusion Criteria:
- Hypersensitivity to fluorine18 FDG
- Hypersensitivity to iodinated contrast media or Gadolinium
- Poorly controlled diabetes
- Acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 mL/min)
- Uncontrolled pain
- Urinary incontinence
- Female patients must not be pregnant and if of child bearing age using adequate contraception
- Breast feeding
- Serious psychiatric comorbidity
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Pilota
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
PETCT scan taken prior to chemotherapy in the radiotherapy treatment position, in conjunction with advanced software to combine this scan with the subsequent radiotherapy planning CT, to more accurately identify the lymphoma target.
Lasso di tempo: 2 years
|
2 years
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RD12/10519
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Radioterapia
-
Yonsei UniversityReclutamentoCarcinoma | Neoplasie del fegato | Carcinoma epatocellulare | EpatocellulareCorea del Sud
-
Chang Gung Memorial HospitalNon ancora reclutamentoOligometastasi cerebraliTaiwan