Colorectal CancerDISCONCT04231175
Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer
A study testing DWI MRI of the pelvis, abdomen and thorax in people with Colorectal Cancer and Peritoneal Carcinomatosis, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Peritoneal Carcinomatosis, MRI
- What is being tested?
- DWI MRI of the pelvis, abdomen and thorax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Oct 2019to 28 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam, 1066CX
Max Lahaye, PhD, MD, +31 20 512 1012, m.lahaye@nki.nl
Carine Sondermeijer, Bsc, +31 20 512 7423, c.sondermeijer@nki.nl
About this study
Official title: Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer Patients; a Multicenter Randomized Trial
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.
Read the detailed description
HYPOTHESIS Staging with dedicated MRI will lead to a reduction of staging laparoscopies and explorative laparotomies in colorectal patients with PM to evaluate whether they may benefit from CRS-HIPEC
OBJECTIVES The goal is to perform a multicenter randomized study to compare a less invasive diagnostic workup ARM A (with MRI and surgical inspection reserved for borderline operable cases on MRI) to the standard diagnostic workup (ARM B, without MRI, with surgical staging to determine resectability based on a MDT decision) of patients with (suspected) peritoneal metastases. Surgical staging laparoscopies may largely be replaced by MRI (only reserved as a problem solver for borderline operable cases in ARM A). If it will be proven that MRI is an accurate, robust and cost-effective staging tool than this will result in a more patient friendly diagnostic workup with less futile surgical procedures.
STUDY DESIGN 4-year multicenter randomized controlled trial
STUDY POPULATION N=272 patients suspected of synchronous or metachronous peritoneal metastases of colorectal origin who are considered for CRS-HIPEC after CT imaging.
EXPERIMENTAL (ARM A) CRS-HIPEC candidates are selected based on MRI and only in borderline cases a surgical inspection will be performed
CONTROL (ARM B) Standard work-up including computed tomography and surgical inspection as appropriate (based on a MDT decision).
MAIN STUDY PARAMETERS/ENDPOINTS
Primary outcome:
Number of preventable unnecessary laparoscopies and explorative laparotomies.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS:
MRI is a standard diagnostic procedure without the use of radiation. The MR sequences, MR-contrast agents and Buscopan (to minimize peristaltic bowel movements) are all commonly used in daily clinical practice. In addition, patients will be asked to drink 1L of pineapple juice 1-2 hours before the MRI (to minimize signal in the bowel lumen and optimize image quality), which is standard procedure in many clinics for MRCP and MR enterography. By acting upon the MRI findings in the experimental arm A, could result into new risks as oppose to standard clinical practice. However by introducing the borderline group ('yellow light' group) to receive diagnostic laparoscopy will minimize the possibility of over-staging a patient that would have received a successful CRS/HIPEC in de control arm. In our internal pilot data of 87 patients considered for CRS/HIPEC, no patients with a PCI of above 24 ended up receiving successful CRS/HIPEC and only 4 of the 15 patients that could have been assigned to the borderline group (were the trail to have run at that time) received successful CRS/HIPEC.
- Conditions
- Colorectal Cancer, Peritoneal Carcinomatosis, MRI
- Being tested
- DWI MRI of the pelvis, abdomen and thorax
- Keywords
- Colorectal cancer, Peritoneal Carcinomatosis, MRI, Randomization
- Medical subject headings
- Colorectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Number of preventable unnecessary laparoscopies and explorative laparotomies defined as
(II) incomplete CRS-HIPEC (R2A/R2B/open-close procedures)
Measured: 4 weeks
Secondary outcomes (7)
- Number of additional extra-peritoneal findings
Number of additional extra-peritoneal findings
Measured: 4 weeks
- Number of early recurrences (with-in 6 months after R1 resection and HIPEC)
- Number of early recurrences (with-in 6 months after R1 resection and HIPEC)
Measured: 6 months
- Diagnostic performance of Peritoneal Cancer Index determined by MRI (MRI-PCI) to predict surgical Peritoneal Cancer Index (S-PCI).
- The Peritoneal Cancer Index (PCI) system reported by Sugerbaker [24] will be determined by indicating the presence of large (>5cm), moderate (<5cm - >0.5cm), small (<0.5cm) or no involvement in 13 abdominal regions
Measured: 6 months
- Inter-observer agreement between different readers for DW-MRI.
Readers will evaluate the following MR criteria that might result in an incomplete CRS with a confidence level score (0 to 5):
- MRI-PCI > 20
- Extensive agglutinated intra-abdominal disease (stomach/liver/spleen/retrohepatic)
- Extensive serosa involvement (>1.5 m bowel resection needed)
- Extensive disease at diaphragmatic level (>1 cm in diameter)
- Extensive extra-abdominal disease (>1 cm in diameter) in patients without neoadjuvant treatment
- Presence and location of intra-abdominal enlarged lymph nodes
- Ascites > 500 ml
- Overall resectability based on MRI findings
Measured: 6 months
Incremental cost-effectiveness ratio
The direct costs will include costs of standard treatment (chemotherapy and cytoreductive surgery), costs of diagnostic work-up (standard and MRI) and treatment of adverse events/surgical complications, follow-up visits, recurrences and palliative care (measured as possible within the trial period). From this the cost effectiveness will be determined.
Measured: 6 months
Quality of Life between diagnostic arms by EORTC-C30 -
The following questionnaire will be used to measure HRQoL in patients EORTC-C30. This will be completed at baseline, 3 \& 6 months following randomisation.
Measured: 6 months
Quality of Life between diagnostic arms by EQ5D5L
The following questionnaire will be used to measure HRQoL in patients EQ5D5L. This will be completed at baseline, 3 \& 6 months following
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start28 Oct 2019
- Primary completion28 Oct 2023 (estimated)
- Study completion28 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multi center randomized trial
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Max Lahaye, PhD MD, Principal investigator, Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231175
- Sponsor's protocol ID
- M19DSC
- Acronym
- DISCO
- Status last verified
- Jan 2020
- First submitted
- 31 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33902498
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer Patients; a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT04231175
- Acronym / sponsor ID
- DISCO / M19DSC
- Conditions
- Colorectal Cancer, Peritoneal Carcinomatosis, MRI
- Keywords
- Colorectal cancer, Peritoneal Carcinomatosis, MRI, Randomization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Oct 2023 (estimated)
- Study completion
- 28 Oct 2023 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HYPOTHESIS Staging with dedicated MRI will lead to a reduction of staging laparoscopies and explorative laparotomies in colorectal patients with PM to evaluate whether they may benefit from CRS-HIPEC
OBJECTIVES The goal is to perform a multicenter randomized study to compare a less invasive diagnostic workup ARM A (with MRI and surgical inspection reserved for borderline operable cases on MRI) to the standard diagnostic workup (ARM B, without MRI, with surgical staging to determine resectability based on a MDT decision) of patients with (suspected) peritoneal metastases. Surgical staging laparoscopies may largely be replaced by MRI (only reserved as a problem solver for borderline operable cases in ARM A). If it will be proven that MRI is an accurate, robust and cost-effective staging tool than this will result in a more patient friendly diagnostic workup with less futile surgical procedures.
STUDY DESIGN 4-year multicenter randomized controlled trial
STUDY POPULATION N=272 patients suspected of synchronous or metachronous peritoneal metastases of colorectal origin who are considered for CRS-HIPEC after CT imaging.
EXPERIMENTAL (ARM A) CRS-HIPEC candidates are selected based on MRI and only in borderline cases a surgical inspection will be performed
CONTROL (ARM B) Standard work-up including computed tomography and surgical inspection as appropriate (based on a MDT decision).
MAIN STUDY PARAMETERS/ENDPOINTS
Primary outcome:
Number of preventable unnecessary laparoscopies and explorative laparotomies.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS:
MRI is a standard diagnostic procedure without the use of radiation. The MR sequences, MR-contrast agents and Buscopan (to minimize peristaltic bowel movements) are all commonly used in daily clinical practice. In addition, patients will be asked to drink 1L of pineapple juice 1-2 hours before the MRI (to minimize signal in the bowel lumen and optimize image quality), which is standard procedure in many clinics for MRCP and MR enterography. By acting upon the MRI findings in the experimental arm A, could result into new risks as oppose to standard clinical practice. However by introducing the borderline group ('yellow light' group) to receive diagnostic laparoscopy will minimize the possibility of over-staging a patient that would have received a successful CRS/HIPEC in de control arm. In our internal pilot data of 87 patients considered for CRS/HIPEC, no patients with a PCI of above 24 ended up receiving successful CRS/HIPEC and only 4 of the 15 patients that could have been assigned to the borderline group (were the trail to have run at that time) received successful CRS/HIPEC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multi center randomized trial
| Arm | Type | Receives |
|---|---|---|
| experimental arm A | Experimental | Diagnostic Test: DWI MRI of the pelvis, abdomen and thoraxpatients 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with suspicion of colorectal peritoneal metastases and considered for CRS/HIPEC
Key exclusion criteria (13 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWI MRI of the pelvis, abdomen and thoraxPatients 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. | Diagnostic test | experimental arm A |
Primary outcome
Number of preventable unnecessary laparoscopies and explorative laparotomies defined as:
Time frame: 4 weeks
(I) patients with a PCI<15 at laparoscopy or PCI>24 at laparotomy (II) incomplete CRS-HIPEC (R2A/R2B/open-close procedures)
Number of preventable unnecessary laparoscopies and explorative laparotomies defined as
Time frame: 4 weeks
(II) incomplete CRS-HIPEC (R2A/R2B/open-close procedures)
7 secondary outcomes
- Number of additional extra-peritoneal findings
Time frame: 4 weeks
- Number of early recurrences (with-in 6 months after R1 resection and HIPEC)
Time frame: 6 months
- Diagnostic performance of Peritoneal Cancer Index determined by MRI (MRI-PCI) to predict surgical Peritoneal Cancer Index (S-PCI).
Time frame: 6 months
- Inter-observer agreement between different readers for DW-MRI.
Time frame: 6 months
Incremental cost-effectiveness ratio
Time frame: 6 months
Quality of Life between diagnostic arms by EORTC-C30 -
Time frame: 6 months
Quality of Life between diagnostic arms by EQ5D5L
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 33902498Engbersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Lahaye, PhD MD principal investigator
Antoni van Leeuwenhoek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DWI MRI of the pelvis, abdomen and thorax in people with Colorectal Cancer and Peritoneal Carcinomatosis, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Max Lahaye, PhD MD (+31 20 512 1012, m.lahaye@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of preventable unnecessary laparoscopies and explorative laparotomies defined as: (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.