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Completed

NCT Number: NCT02781935

Diffusion-Weighted MRI for Liver Metastasis

The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck Universitaetsklinik, Innsbruck, Austria

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About this study

The advancements of systemic and local therapies for complex CRLM have led to the increased incidence of DLMs. It is hypothesized that DW-MRI imaging could distinguish between a metastasis not completely sterilized by conversion therapy and a sterilized scar (non-viable tumor). If this can be demonstrated, the use of DW-MRI could make a significant impact on the surgical decision making process by providing surgeons a more reliable guide to decide whether to leave behind or to resect/ablate a site of DLM. Most importantly, this surgical choice can also have a significant impact on patient outcomes as it may impact the risk of local recurrence and the need for re-operation.The possibility of improving surgical management of complex CRLM is foreseen if the benefit of observing or resecting small residual metastases and DLMs is clarified through a multi-center and international prospective study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Eligibility:

  • Contrast-enhanced thorax, abdomen and pelvic CT scan (with at least portal venous phase for the liver) at diagnosis and right before surgery are available
  • Multiparametric MRI at baseline and right before surgery are available (T1/T2, DW-MRI and contrast enhanced MRI).
  • WHO performance status of 0 or 1
  • Previous treatments (chemotherapy, surgery) for primary, liver and extra-hepatic metastases are allowed.
  • No other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer gleason score ≤ 6, and basal/squamous cell carcinoma of the skin
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study

Criteria for Enrollment

  • Conversion therapy is either being given or completed
  • Patient is suitable for hepatic resection based on the assessment of MDT composed of at least an expert liver/colorectal surgeon, Gastrointestinal (GI) radiologist and oncologist prior to any liver surgery
  • Hepatic resection is scheduled to take place within 8 weeks of latest imaging

Exclusion criteria

  • Contraindications to any contrast agents for CT and MRI or MRI procedure
  • Pregnancy
  • Significant comorbidity that will preclude either conversion therapy or surgery

Treatment and study plan

DW-MRI

Procedure

DW-MRI combined with Contrast Enhanced MRI will be used to confirm the status of disappearing liver metastasis prior to surgery and will be compared to findings from either histopathology of resected lesions (Rubbia-Brandt Classification of Tumor regression grading) or follow-up imaging of lesions left behind (either CT scan or MRI) after surgery. MRI will be used during the follow-up period to confirm recurrences from a previous site of DLM.

Primary outcomes

  1. Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)

    Time frame: 2 years after surgery

Secondary outcomes

  1. NPV of diagnostic imaging among the group of resected confirmed DLMs

    Time frame: 2 years after the surgery

  2. NPV of diagnostic imaging in the group of confirmed DLMs that were left in place

    Time frame: 2 years after ther surgery

  3. NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review

    Time frame: 2 years after the surgery

  4. Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy

    Time frame: 2 years after the surgery

  5. Correlation between findings on DW-MRI to histopathology, recurrence rate, complication rates, PFS and OS

    Time frame: 2 years after initial surgery

  6. Long term outcomes of patients who underwent surgery in terms of: - recurrence rates for 2 years after surgery - progression free survival for 2 years after surgery - overall survival for 2 years after surgery

    Time frame: 2 years after initial surgery

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Collaborators

  • European Society of Surgical Oncology
  • Japan Clinical Oncology Group

Registry information

Official study title

Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning

Acronym: DREAM

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
May 25, 2016
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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