Radiomics in Rectal Cancer

NCT05331040 | Unknown

• 1 other identifier: 2018ON004
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study aims to investigate whether initial imaging characteristics of rectal cancer on Magnetic Resonance Imaging (MRI) correlate with the underlying tumour pathology and oncological outcomes such as response to treatment. Using radiomic features, calculated using new high throughput analysis of previously acquired imaging, a statistically robust prognostic model will be created with the overall aim of developing imaging biomarkers.

Conditions

Rectal Cancer

Keywords

Radiomics; Prognostic modelling

Outcome Measures

Primary Outcomes (1)

• Model

  Development of a radiomics based prognostic model to help/guide multidisciplinary team and shared care decisions in the management of rectal cancer patients.

  from baseline characteristics

Interventions

MRI DIAGNOSTIC_TEST

Radiomic analysis of newly diagnosed rectal cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As per inclusion criteria.

You may qualify if:

• All patients with newly diagnosed rectal cancer within NHSG for the five year period (2010-2015) who had a pre-operative staging MRI at NHSG for whom pathology reported within NHSG.

You may not qualify if:

• Those patients whose MRI scans are degraded from artifact (such as metal artifact from hip replacements)
• Patients lost to follow-up or moved out with NHS Grampian during follow-up.
• Patients with incomplete clinical or pathological data.

Sponsors & Collaborators

• NHS Grampian: lead
• Industrial centre for Artificial intelligence Research: collaborator
• Roland Sutton Academic Trust: collaborator
• Innovate UK: collaborator
• University of Aberdeen: collaborator

Study Sites (1)

NHS Grampian

Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom

Location

Related Publications (16)

• Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006.

  PMID: 24892406 BACKGROUND

• Al-Sukhni E, Milot L, Fruitman M, Beyene J, Victor JC, Schmocker S, Brown G, McLeod R, Kennedy E. Diagnostic accuracy of MRI for assessment of T category, lymph node metastases, and circumferential resection margin involvement in patients with rectal cancer: a systematic review and meta-analysis. Ann Surg Oncol. 2012 Jul;19(7):2212-23. doi: 10.1245/s10434-011-2210-5. Epub 2012 Jan 20.

  PMID: 22271205 BACKGROUND

• Bang JI, Ha S, Kang SB, Lee KW, Lee HS, Kim JS, Oh HK, Lee HY, Kim SE. Prediction of neoadjuvant radiation chemotherapy response and survival using pretreatment [(18)F]FDG PET/CT scans in locally advanced rectal cancer. Eur J Nucl Med Mol Imaging. 2016 Mar;43(3):422-31. doi: 10.1007/s00259-015-3180-9. Epub 2015 Sep 4.

  PMID: 26338180 BACKGROUND

• Brown GT, Cash B, Alnabulsi A, Samuel LM, Murray GI. The expression and prognostic significance of bcl-2-associated transcription factor 1 in rectal cancer following neoadjuvant therapy. Histopathology. 2016 Mar;68(4):556-66. doi: 10.1111/his.12780. Epub 2015 Sep 17.

  PMID: 26183150 BACKGROUND

• Bundschuh RA, Dinges J, Neumann L, Seyfried M, Zsoter N, Papp L, Rosenberg R, Becker K, Astner ST, Henninger M, Herrmann K, Ziegler SI, Schwaiger M, Essler M. Textural Parameters of Tumor Heterogeneity in (1)(8)F-FDG PET/CT for Therapy Response Assessment and Prognosis in Patients with Locally Advanced Rectal Cancer. J Nucl Med. 2014 Jun;55(6):891-7. doi: 10.2967/jnumed.113.127340. Epub 2014 Apr 21.

  PMID: 24752672 BACKGROUND

• Coroller TP, Grossmann P, Hou Y, Rios Velazquez E, Leijenaar RT, Hermann G, Lambin P, Haibe-Kains B, Mak RH, Aerts HJ. CT-based radiomic signature predicts distant metastasis in lung adenocarcinoma. Radiother Oncol. 2015 Mar;114(3):345-50. doi: 10.1016/j.radonc.2015.02.015. Epub 2015 Mar 4.

  PMID: 25746350 BACKGROUND

• De Cecco CN, Ciolina M, Caruso D, Rengo M, Ganeshan B, Meinel FG, Musio D, De Felice F, Tombolini V, Laghi A. Performance of diffusion-weighted imaging, perfusion imaging, and texture analysis in predicting tumoral response to neoadjuvant chemoradiotherapy in rectal cancer patients studied with 3T MR: initial experience. Abdom Radiol (NY). 2016 Sep;41(9):1728-35. doi: 10.1007/s00261-016-0733-8.

  PMID: 27056748 BACKGROUND

• Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.

  PMID: 26579733 BACKGROUND

• Jalil O, Afaq A, Ganeshan B, Patel UB, Boone D, Endozo R, Groves A, Sizer B, Arulampalam T. Magnetic resonance based texture parameters as potential imaging biomarkers for predicting long-term survival in locally advanced rectal cancer treated by chemoradiotherapy. Colorectal Dis. 2017 Apr;19(4):349-362. doi: 10.1111/codi.13496.

  PMID: 27538267 BACKGROUND

• Kumar V, Gu Y, Basu S, Berglund A, Eschrich SA, Schabath MB, Forster K, Aerts HJ, Dekker A, Fenstermacher D, Goldgof DB, Hall LO, Lambin P, Balagurunathan Y, Gatenby RA, Gillies RJ. Radiomics: the process and the challenges. Magn Reson Imaging. 2012 Nov;30(9):1234-48. doi: 10.1016/j.mri.2012.06.010. Epub 2012 Aug 13.

  PMID: 22898692 BACKGROUND

• McClelland D, Murray GI. A Comprehensive Study of Extramural Venous Invasion in Colorectal Cancer. PLoS One. 2015 Dec 15;10(12):e0144987. doi: 10.1371/journal.pone.0144987. eCollection 2015.

  PMID: 26671331 BACKGROUND

• Parnaby CN, Scott NW, Ramsay G, MacKay C, Samuel L, Murray GI, Loudon MA. Prognostic value of lymph node ratio and extramural vascular invasion on survival for patients undergoing curative colon cancer resection. Br J Cancer. 2015 Jul 14;113(2):212-9. doi: 10.1038/bjc.2015.211. Epub 2015 Jun 16.

  PMID: 26079302 BACKGROUND

• Quirke P, Durdey P, Dixon MF, Williams NS. Local recurrence of rectal adenocarcinoma due to inadequate surgical resection. Histopathological study of lateral tumour spread and surgical excision. Lancet. 1986 Nov 1;2(8514):996-9. doi: 10.1016/s0140-6736(86)92612-7.

  PMID: 2430152 BACKGROUND

• Smith N, Brown G. Preoperative staging of rectal cancer. Acta Oncol. 2008;47(1):20-31. doi: 10.1080/02841860701697720.

  PMID: 17957502 BACKGROUND

• Vignali A, De Nardi P. Multidisciplinary treatment of rectal cancer in 2014: where are we going? World J Gastroenterol. 2014 Aug 28;20(32):11249-61. doi: 10.3748/wjg.v20.i32.11249.

  PMID: 25170209 BACKGROUND

• Yip SS, Aerts HJ. Applications and limitations of radiomics. Phys Med Biol. 2016 Jul 7;61(13):R150-66. doi: 10.1088/0031-9155/61/13/R150. Epub 2016 Jun 8.

  PMID: 27269645 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rosalind Mitchell-Hay

  NHS Grampian & University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Radiologist

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: May 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2025
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

GB (1)