Bedömning av respons på nCRT för GEJ-cancer med hjälp av en helt integrerad PET/MRI (Escape)
Förutsägelse av bedömning av respons på neoadjuvant kemo-radioterapi (nCRT) för esofagus- och gastroesofageal Junction Cancer (GEJ) med hjälp av en helt integrerad PET/MRI
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Milan, Italien, 20132
- Deaprtment of Radiology, IRCCS Ospedale San Raffaele
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Response to neoadjuvant treatment -MRI
Tidsram: 0-36 months
|
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
Tidsram: 0-36 months
|
PET component -quantitative evaluation and delta between timepoints |
0-36 months
|
|
Response to neoadjuvant treatment - Histology
Tidsram: 0-36 months
|
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
Tidsram: 0-36 months
|
Radiomic features extracted from hybrid imaging |
0-36 months
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Imaging parameters as potential predictors of tumor response
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Early regression model (ERI)
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Francesco De Cobelli, MD, IRCCS Ospedale San Raffaele
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Escape
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