PET-CT and DWI-MRI in evaluating and predicting response to neoadjuvant chemoradiotherapy in esophageal cancer patients: PET/MRI-OES-1 study

Phase 2

Completed

• Conditions: esophageal cancer response; 10017990; 10017991

• Registration Number: NL-OMON41028
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Histologically proven esophageal cancer (SCC and AC).
2. Age 18 years or older.
3. Able to give written informed consent before registration.
4. T2-T4aN0M0 or T1-T4aN1-3M0 esophageal cancer.
5. Potentially curatively (R0) resectable tumor.
6. Tumor should have sufficient FDG-baseline uptake (in case routine baseline FDG-PET/CT shows insufficient uptake no additional MRI will be made).
7. Able to tolerate PET-CT and DWI-MRI as required by protocol.
8. Patients eligible for neo-adjuvant chemoradiotherapy (CRT), including a Karnofsky Performance Score (KPS) >= 70% / WHO>2, adequate renal, hepatic, hematological function.
9. No prior chemotherapy or mediastinal radiotherapy allowed.
10. Written informed consent.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Non-resectable tumours
2. Proven distant metastases
3. Prior malignancy except in-situ cervical lesions and/or non-melanoma skin cancer in the past 5 years.
4. Poorly controlled diabetes
5. Medical comorbidity preventing from surgery/preop CRT
6. General contraindications to MRI:
- implanted pacemaker/serious claustrophobia
- aneurysmal clips/metal implants in field of view
6. Major obesity (BMI > 40)
7. Active esophagitis
8. Breast feeding/Pregnancy

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Tumor response (complete or partial) during and after neo-adjuvant CRT.<br /><br>Clinical response will be assessed by PET/CT (SUVmax) and by DWI-MRI (ADC; the<br /><br>stronger the diffusion, the greater the diffusion coefficient) either alone or<br /><br>in a combined approach (PET/MRI) when available. The assessed clinical response<br /><br>(cR) will be correlated to the pathologic response (pR) on the resected<br /><br>specimen according to a standard protocol.<br /><br>The value of both imaging methods will be determined alone and combined to<br /><br>assess both early (around 2 weeks) and late responses (>= 2 weeks after the end<br /><br>of CRT) . </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>Determining disease free survival (DFS) after different response type (clinical<br /><br>complete response =cCR or pathologic complete response = pCR) at T1 (early<br /><br>volumetric and functional response) and at T2 (post CRT=histological response<br /><br>/volumetric and functional) comparing pathologic status with blinded reading of<br /><br>PET/CT and DWI-MRI from two independent radiologists/nuclear medicine<br /><br>physicians.<br /><br>Assessment of no response or progression at T1 for a better selection of<br /><br>patients to early definitive surgery. Moreover, at T1 cCR will be assessed and<br /><br>at T2 cCR and pCR will be determined.<br /><br>Determining the changes in radiotherapy target volume delineation by the<br /><br>additional use of MRI. </p><br>