- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01187641
Comparison of the Diagnostic Accuracy of 3D Volume Acquisition MRI With CT in Staging Colonic Cancer
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The patient will proceed with their usual colon cancer assessment and treatment, including colonoscopy with biopsy and histology and preoperative CT chest abdomen and pelvis. In addition, patients who enroll in the study will have 2 preoperative MRIs of their abdomen and pelvis performed. One of these will be performed on a 1.5T and the other will be performed on a 3.0T MRI scanner. We will use 20mg of IM buscopan to reduce bowel mobility for each scan. A coronal scout scan will be taken to identify the tumour and select the target volume. IV gadolinium (a contrast agent routinely used in MRI scans to help identify different tissues) will be administered, and a 3D VIBE scan (T1 weighted) will be performed of the target volume. The liver will also be imaged at this time to look for liver metastases. A T2 weighted 3D volume acquisition will then be obtained of the target volume containing the tumour (and its lymphatic drainage).
The MRI will be independently reported by an expert without knowledge of the results of any other investigations. The results of the MRI scan will then be made available to the clinical team. The patient will then proceed as normal with any other investigation which the clinical team feel is necessary, and be treated as normal for their colon cancer. The patient will proceed with their surgery as normal, and the specimen removed at the time of the operation will be examined in the pathology laboratory to determine the exact stage of the cancer.
The accuracy of CT and MRI in staging colon cancer will then be determined against the reference standard provided by the histology examination.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Surrey
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Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
- The Royal Marsden NHS Foundation Trust
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- patients undergoing treatment for colon cancer
- patients undergoing primary surgery for colon cancer and who do not require neo-adjuvant therapy on the basis of their pre-operative CT
Exclusion Criteria:
- age <18
- unable to consent
- consent withheld or withdrawn
- Unable to have an MRI (e.g pacemaker, metal implant)
- Allergy or contraindications to busocopam, gadolinium, small bowel contrast agent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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colon cancer
patients undergoing treatment for colon cancer
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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The primary endpoint will be the accuracy of MRI and CT in determining T stage using histology as the gold standard, on a per patient basis.
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Sekundære resultatmål
Resultatmål |
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Secondary endpoints will be the accuracy of CT and MRI in determining N stage, depth of invasion beyond the muscularis propria, and EMVI.
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We will also compare the accuracy of 1.5T against 3.0T MRI scans, and T2 weighted against T1 weighted images
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Prof Gina Brown, Royal Marsden NHS Foundation Trust
Publikationer og nyttige links
Generelle publikationer
- Hunter C, Blake H, Jeyadevan N, Abulafi M, Swift I, Toomey P, Brown G. Local staging and assessment of colon cancer with 1.5-T magnetic resonance imaging. Br J Radiol. 2016 Aug;89(1064):20160257. doi: 10.1259/bjr.20160257. Epub 2016 May 26.
- Hunter C, Siddiqui M, Georgiou Delisle T, Blake H, Jeyadevan N, Abulafi M, Swift I, Toomey P, Brown G. CT and 3-T MRI accurately identify T3c disease in colon cancer, which strongly predicts disease-free survival. Clin Radiol. 2017 Apr;72(4):307-315. doi: 10.1016/j.crad.2016.11.014. Epub 2017 Jan 31.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCR3370
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