Vurdering av respons på nCRT for GEJ-kreft ved bruk av en fullt integrert PET/MRI (Escape)
Prediksjon av vurdering av respons på neoadjuvant kjemo-radioterapi (nCRT) for esophageal og gastroøsofageal Junction Cancer (GEJ) ved bruk av en fullt integrert PET/MRI
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.
The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.
- PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)
- An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT
- Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.
- 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT
- Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Milan, Italia, 20132
- Deaprtment of Radiology, IRCCS Ospedale San Raffaele
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (AC) or squamous cell carcinoma (SCC) for which an Ivor-Lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated;
- visible tumor on pre-treatment imaging;
- ≥ 18 years of age;
- signed informed consent.
Exclusion Criteria:
- - incomplete preoperative imaging assessment;
- contraindications to neoadjuvant treatment;
- contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents);
- inability to complete imaging examinations (i.e. severe claustrophobia);
- contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed));
- pregnant or lactating women
- severe hypersensitivity to gadobutrol or fludeoxyglucose F18.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Hybrid PET/MRI
For the purposes of the study, in addition to standard imaging (EUS and CT scan), a fully integrated hybrid PET/MRI (PET/MRI) study with FDG will replace the Standard PET (pre-surgical evaluation) used for evaluating distant metastases and will be considered as the add-on procedure at three time points. The additional evaluation for patients is that during nCRT treatment. |
An additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Response to neoadjuvant treatment -MRI
Tidsramme: 0-36 months
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MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints |
0-36 months
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Response to neoadjuvant treatment -PET
Tidsramme: 0-36 months
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PET component -quantitative evaluation and delta between timepoints |
0-36 months
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Response to neoadjuvant treatment - Histology
Tidsramme: 0-36 months
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Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry |
0-36 months
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Response to neoadjuvant treatment -Radiomics
Tidsramme: 0-36 months
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Radiomic features extracted from hybrid imaging |
0-36 months
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Imaging parameters as potential predictors of tumor response
Tidsramme: 0- 48 months
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Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment |
0- 48 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Early regression model (ERI)
Tidsramme: 0- 60 months
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Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment |
0- 60 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Francesco De Cobelli, MD, IRCCS Ospedale San Raffaele
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Escape
Legemiddel- og utstyrsinformasjon, studiedokumenter
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