Using PET/MRI to predict response in esophageal cancer treatment
Prediction of Assessment of Response to Neoadjuvant Chemo-Radio-Therapy (nCRT) for Esophageal and Gastroesophageal Junction Cancer (GEJ) Using a Fully Integrated PET/MRI
This study is testing if PET/MRI imaging can help predict how well patients with esophageal cancer respond to their treatment before, during, and after chemotherapy and radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT04359732 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of PET/MRI imaging as a predictor for patients with esophageal and junctional cancers undergoing neoadjuvant chemoradiotherapy (nCRT). It is a prospective, observational study that will enroll patients with biopsy-proven, potentially resectable cancers scheduled for nCRT. The study will utilize PET/MRI to assess tumor response at various stages: before treatment, during nCRT, and after treatment completion, followed by surgical intervention. Histopathological analysis of excised tumors will also be conducted to gather comprehensive data on treatment response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven esophageal or junctional carcinomas who are scheduled for nCRT.
Not a fit: Patients with contraindications to imaging or surgery, or those with distant metastatic disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of predicting treatment responses in esophageal cancer, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promising results using advanced imaging techniques like PET/MRI in cancer treatment assessment, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milano
- Deaprtment of Radiology, IRCCS Ospedale San Raffaele — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco De Cobelli, MD — IRCCS Ospedale San Raffaele
- Study coordinator: Francesco De Cobelli, MD
- Email: decobelli.francesco@hsr.it
- Phone: +3926432529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.