NCT02439086

Brief Summary

The purpose of this study is to determine whether 18F-FDG-PET-CT and texture analysis of MRI performed 9 weeks after Neoadjuvant Chemo-radiotherapy in patients with locally advanced rectal cancer has the ability to identify patients with Complete Response.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

April 23, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

April 23, 2015

Last Update Submit

May 8, 2015

Conditions

Rectal Neoplasms

Keywords

rectal cancerneoadjuvant chemoradiotherapylong course radiotherapyresponse

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Texture analysis PET-CT

    Sensitivity will be calculated from 2x2 contingency table.

    6 months

Secondary Outcomes (2)

  • Correlation between tumour response parameters to survival.

    6 months

  • Accuracy of Texture analysis MRI

    6 months

Study Arms (1)

Long Course Radiotherapy

EXPERIMENTAL

all patients diagnosed with rectal cancer, amenable for neoadjuvant chemoradiotherapy, who agree to participate in this study will undergo 2 PET-CT scans: at baseline and 9 weeks after commencing therapy.

Device: PET-CT Scan

Interventions

PET-CT ScanDEVICE

patients will have 2 PET CT scans: one before radiotherapy, and one 9 weeks after.

Long Course Radiotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with biopsy-proven confirmed rectal cancer
  • MRI stage: T3/T4 and/or N1/N0.
  • No contraindication to MRI and PET-CT.

You may not qualify if:

  • Contraindication to MRI and/or PET-CT.
  • Inability to consent.
  • Severe claustrophobia.
  • Distant metastases.
  • Synchronous tumour.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colchester General Hospital

Colchester, CO4 5JL, United Kingdom

Location

Related Publications (7)

  • Arulampalam TH, Costa DC, Loizidou M, Visvikis D, Ell PJ, Taylor I. Positron emission tomography and colorectal cancer. Br J Surg. 2001 Feb;88(2):176-89. doi: 10.1046/j.1365-2168.2001.01657.x.

    PMID: 11167864BACKGROUND

  • 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: 24752672BACKGROUND

  • HABR-GAMA, A., PEREZ, R., LYNN, P., SãO JULIãO, G. and GAMA RODRIGUES, J., 2012. Selective non-operative management of distal rectal cancer: The Watch & Wait Protocol. In: R. SCHIESSEL and P. METZGER, eds, Springer Vienna, pp. 43-53.

    BACKGROUND

  • Habr-Gama A, Perez RO, Nadalin W, Sabbaga J, Ribeiro U Jr, Silva e Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results. Ann Surg. 2004 Oct;240(4):711-7; discussion 717-8. doi: 10.1097/01.sla.0000141194.27992.32.

    PMID: 15383798BACKGROUND

  • Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6.

    PMID: 20692872BACKGROUND

  • Niccoli-Asabella A, Altini C, De Luca R, Fanelli M, Rubini D, Caliandro C, Montemurro S, Rubini G. Prospective analysis of 18F-FDG PET/CT predictive value in patients with low rectal cancer treated with neoadjuvant chemoradiotherapy and conservative surgery. Biomed Res Int. 2014;2014:952843. doi: 10.1155/2014/952843. Epub 2014 May 4.

    PMID: 24877151BACKGROUND

  • Aker M, Ganeshan B, Afaq A, Wan S, Groves AM, Arulampalam T. Magnetic Resonance Texture Analysis in Identifying Complete Pathological Response to Neoadjuvant Treatment in Locally Advanced Rectal Cancer. Dis Colon Rectum. 2019 Feb;62(2):163-170. doi: 10.1097/DCR.0000000000001224.

    PMID: 30451764DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Tan Arulampalam, MD

    ICENI Centre director

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Medhat S Alaker, MCh, MD(Res)

CONTACT

+447746147851medhat.alaker@nhs.net

Tan Arulampalam, MD

CONTACT

01206742456laptan1@yahoo.org.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 8, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

GB(1)