Hyperthermic Intraperitoneal ChemotherapyNCT05063019
Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
A study testing MRI in people with Hyperthermic Intraperitoneal Chemotherapy and Cytoreductive Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a prospective observational study which will recruit 90 participants over a three-year period to investigate whether adding magnetic resonance imaging and enterography to routine computed tomography study can better predict the extend of peritoneal carcinomatosis over computed tomography alone. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Carcinomatosis
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 31 Aug 2024
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with peritoneal carcinomatosis diagnosed by computed tomography
- Schedule for operation at our institute
Who cannot join
- Age < 20 years old
- Renal function impairment or acute renal failure
- Contraindications for magnetic resonance imaging
- Primary tumor not origins from colorectal cancer, gastric cancer or ovarian cancer
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Chiayi City, 61363
Chia-Ni Lin, MA, +886 5 3621 000 ext. 2627, lcn6979@cgmh.org.tw
Li-Wen Lee, MD, PhD, +886 5 3621 000 ext. 2627, m4572@cgmh.org.tw
About this study
Official title: Adding Value of Magnetic Resonance Imaging and Magnetic Resonance Enterography for the Pre-operative Assessment of Imaging Peritoneal Cancer Index in Patients With Peritoneal Carcinomatosis
This is a prospective observational study which will recruit 90 participants over a three-year period to investigate whether adding magnetic resonance imaging and enterography to routine computed tomography study can better predict the extend of peritoneal carcinomatosis over computed tomography alone.
Read the detailed description
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a new option for patients with peritoneal carcinomatosis and the effectiveness of HIPEC depends on the extend of disease. Currently, pre-operative imaging peritoneal cancer index (PCI) is used to predict the intraoperative tumor extend and completeness of cytoreduction. However, the investigators' previous study and literature review show that imaging PCI usually underestimated intraoperative PCI, resulting in subsequent Open-Close operation. The investigators hypothesize that magnetic resonance imaging (MRI) is a better predictor of the intra-operative PCI than computed tomography (CT), and MR Enterography can better represent tumor deposits in the small intestine. This study aims to test whether the addition of MRI and MR Enterography to CT study improves the prediction performance of the intraoperative PCI and completeness of optimal cytoreduction over CT alone.
- Conditions
- Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Carcinomatosis
- Being tested
- MRI
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Cancer Index, Magnetic Resonance Enterography
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Magnetic resonance imaging and enterography before surgery
| Study group | Role | What they receive |
|---|---|---|
| Magnetic resonance imaging and enterography following computed tomography | Experimental | Magnetic resonance imaging and enterography will be performed after computed tomography but before surgery. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT
The Sugarbaker's Peritoneal Cancer Index scores according to the MR enterography and CT images will be calculated pre-operatively and will be compared to the standard PCI scores obtained during operation. Basically, the scoring system divides the abdominopelvic cavity into 13 separate regions, and each region is scored 0-3 points as follows: 0 point, the absence of tumor; 1 point, tumors < 0.5 cm in diameter; 2 points, tumors 0.5-5 cm in diameter; 3 points, tumors > 5 cm in diameter.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Sep 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperthermic Intraperitoneal ChemotherapyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ni Lin, MA, Principal investigator, Chang Gung Memorial Hospital, Chiayi, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063019
- Sponsor's protocol ID
- 202100965A3
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Value of Magnetic Resonance Imaging and Magnetic Resonance Enterography for the Pre-operative Assessment of Imaging Peritoneal Cancer Index in Patients With Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT05063019
- Acronym / sponsor ID
- 202100965A3
- Conditions
- Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Carcinomatosis
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Cancer Index, Magnetic Resonance Enterography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 30 Sep 2021 (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.
This is a prospective observational study which will recruit 90 participants over a three-year period to investigate whether adding magnetic resonance imaging and enterography to routine computed tomography study can better predict the extend of peritoneal carcinomatosis over computed tomography alone.
Detailed description
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a new option for patients with peritoneal carcinomatosis and the effectiveness of HIPEC depends on the extend of disease. Currently, pre-operative imaging peritoneal cancer index (PCI) is used to predict the intraoperative tumor extend and completeness of cytoreduction. However, the investigators' previous study and literature review show that imaging PCI usually underestimated intraoperative PCI, resulting in subsequent Open-Close operation. The investigators hypothesize that magnetic resonance imaging (MRI) is a better predictor of the intra-operative PCI than computed tomography (CT), and MR Enterography can better represent tumor deposits in the small intestine. This study aims to test whether the addition of MRI and MR Enterography to CT study improves the prediction performance of the intraoperative PCI and completeness of optimal cytoreduction over CT alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic resonance imaging and enterography following computed tomography | Experimental | Diagnostic Test: MRIMagnetic resonance imaging and enterography will be performed after computed tomography but before surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with peritoneal carcinomatosis diagnosed by computed tomography
- Schedule for operation at our institute
Key exclusion criteria (4 listed)
- Age < 20 years old
- Renal function impairment or acute renal failure
- Contraindications for magnetic resonance imaging
- Primary tumor not origins from colorectal cancer, gastric cancer or ovarian cancer
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 |
|---|---|---|
| MRIMagnetic resonance imaging and enterography before surgery | Diagnostic test | Magnetic resonance imaging and enterography following computed tomography |
Primary outcome
Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT
Time frame: 36 months
The Sugarbaker's Peritoneal Cancer Index scores according to the MR enterography and CT images will be calculated pre-operatively and will be compared to the standard PCI scores obtained during operation. Basically, the scoring system divides the abdominopelvic cavity into 13 separate regions, and each region is scored 0-3 points as follows: 0 point, the absence of tumor; 1 point, tumors < 0.5 cm in diameter; 2 points, tumors 0.5-5 cm in diameter; 3 points, tumors > 5 cm in diameter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
Related trials for Hyperthermic Intraperitoneal Chemotherapy
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Not yet recruitingPhase 2
Application of Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (Diagnosis)
Not yet recruitingObservational study
Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases
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Active, not recruitingPhase 1
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer
RecruitingPhase 2
HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer
Locally Advanced Gastric Cancer, Gastric Adenocarcinoma
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.
Chia-Ni Lin, MA principal investigator
Chang Gung Memorial Hospital, Chiayi, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Hyperthermic Intraperitoneal Chemotherapy and Cytoreductive Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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 Oct 2021. 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 Taiwan. 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 Chia-Ni Lin, MA (+886 5 3621 000 ext. 2627, lcn6979@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2021.