NCT04231175

Brief Summary

MRI is a potentially powerful tool to reliably determine the intra-abdominal tumor load and relations with intra-abdominal organs. In recent years diffusion weighted MRI has proven its value as a highly sensitive technique to detect small malignant disease in a wide variety of cancers \[1-3\]. However, literature concerning the clinical impact of detecting peritoneal metastases with MRI is very limited. Therefore, there is a need for a large randomized multicenter trial to determine whether dedicated MRI can be used as a selection tool for CRS-HIPEC candidates in daily practice.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2023

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

October 31, 2019

Last Update Submit

January 13, 2020

Conditions

Colorectal CancerPeritoneal CarcinomatosisMRI

Keywords

Colorectal cancerPeritoneal CarcinomatosisMRIRandomization

Outcome Measures

Primary Outcomes (2)

  • Number of preventable unnecessary laparoscopies and explorative laparotomies defined as:

    (I) patients with a PCI\<15 at laparoscopy or PCI\>24 at laparotomy (II) incomplete CRS-HIPEC (R2A/R2B/open-close procedures)

    4 weeks

  • Number of preventable unnecessary laparoscopies and explorative laparotomies defined as

    (II) incomplete CRS-HIPEC (R2A/R2B/open-close procedures)

    4 weeks

Secondary Outcomes (7)

  • - Number of additional extra-peritoneal findings

    4 weeks

  • - Number of early recurrences (with-in 6 months after R1 resection and HIPEC)

    6 months

  • - Diagnostic performance of Peritoneal Cancer Index determined by MRI (MRI-PCI) to predict surgical Peritoneal Cancer Index (S-PCI).

    6 months

  • - Inter-observer agreement between different readers for DW-MRI.

    6 months

  • Incremental cost-effectiveness ratio

    6 months

  • +2 more secondary outcomes

Study Arms (2)

experimental arm A

EXPERIMENTAL

patients will undergo dedicated MRI imaging of the pelvis, abdomen, and thorax. Based on the findings of the MRI scan patients will be allocated to one of the diagnostic/treatment options

Diagnostic Test: DWI MRI of the pelvis, abdomen and thorax

arm B

NO INTERVENTION

patients will undergo the current standard diagnostic work-up of DLS at indication (MDT decision) and otherwise continue to CRS-HIPEC.

Interventions

DWI MRI of the pelvis, abdomen and thoraxDIAGNOSTIC_TEST

Patients in Arm A will receive a MRI scan of their pelvis, abdomen, and thorax before possible surgery. During the MRI standard Gadolinium contrast agent and Buscopan is intravenously administered, which is standard clinical practice in abdominal MR imaging. Total scan time is 35 minutes and includes T2 weighted, T1 weighted, Diffusion weighted and dynamic contrast enhanced imaging of the abdomen and the thorax. The findings of this scan will be used to determine whether to proceed with CRS/HIPEC, DLS and then possibly CRS-HIPEC, or palliative care.

experimental arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspicion of colorectal peritoneal metastases and considered for CRS/HIPEC
  • Age ≥18 years
  • Written and signed informed consent
  • WHO 0-2
  • Able and willing to drink 1 liter of pineapple or blueberry juice

You may not qualify if:

  • \- Patients with contraindications for the MRI:
  • Patients who have a heart pacemaker may not have an MRI scan
  • Patients who have a metallic foreign body (metal sliver) in their body
  • Patients with severe claustrophobia
  • Ineligible to receive gadofosveset (Gadolinium) contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate \<30 ml/min/1.73m2)
  • Ineligible to receive Buscopan
  • Allergy for pineapple juice and blueberry juice.
  • Patients with clinical contraindications for CRS/HIPEC
  • Patients with radiological contra-indications for CRS/HIPEC observed on CT thorax/abdomen
  • Massive mesenteric or small bowel involvement which would lead to short bowel syndrome if adequately resected
  • Extra-peritoneal metastases for which CRS/HIPEC is not justifiable (such as lung metastases, skeletal metastases, and liver metastases)
  • Inoperable retroperitoneal lymphadenopathy
  • Patients with a known additional malignancy, unless o treated with curative intent at least five years ago. in situ cancers, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have undergone potentially curative therapy within the past five years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

RECRUITING

Related Publications (1)

  • Engbersen MP, Rijsemus CJV, Nederend J, Aalbers AGJ, de Hingh IHJT, Retel V, Lambregts DMJ, Van der Hoeven EJRJ, Boerma D, Wiezer MJ, De Vries M, Madsen EVE, Brandt-Kerkhof ARM, Van Koeverden S, De Reuver PR, Beets-Tan RGH, Kok NFM, Lahaye MJ. Dedicated MRI staging versus surgical staging of peritoneal metastases in colorectal cancer patients considered for CRS-HIPEC; the DISCO randomized multicenter trial. BMC Cancer. 2021 Apr 26;21(1):464. doi: 10.1186/s12885-021-08168-x.

    PMID: 33902498DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsPeritoneal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAbdominal NeoplasmsPeritoneal Diseases

Study Officials

  • Max Lahaye, PhD MD

    Antoni van Leeuwenhoek

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Lahaye, PhD MD

CONTACT

+31 20 512 1012m.lahaye@nki.nl

Carine Sondermeijer, Bsc

CONTACT

+31 20 512 7423c.sondermeijer@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: multi center randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

January 18, 2020

Study Start

October 28, 2019

Primary Completion

October 28, 2023

Study Completion

October 28, 2023

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)