Can DW MRI Predict Outcome During Radiotherapy for Head and Neck Cancer?

NCT02497573 | Unknown

• 1 other identifier: GN15ON249
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Around 50% of patients with locally advanced H\&N cancer fail to achieve loco-regional control. Currently it cannot be predicted, during treatment, who will fall into this group of non-responders. This study is designed to assess the value of DW MRI as a predictive biomarker of response to radiotherapy in intermediate and high risk OPSCC.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• change in composite ADC

  Apparent Diffusion Coefficient measured at each MRI for each target lesion and the % change in each target lesion will be recorded at MRI2, in comparison with MRI1

  3 weeks

• Relapse status

  Relapse status (control or failure), for each target lesion, will be recorded at the 18 month time point and compared with baseline. Control is defined as absence of any new mass, serial reduction in size or unchanged size of residual mass. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.

  18 months

Secondary Outcomes (1)

• Time to Relapse

  Up to 22 Months

Interventions

Diffuse Weighted MRI OTHER

The DW MRI scans will be used to measure ADC and to calculate change in ADC between the 2 scans. Each scan will take approximately 30 minutes. Images will be acquired and analysed as per the separate scanning protocol.

Eligibility Criteria

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

Study Population

Patients with intermediate or high risk oropharyngeal squamous cell carcinoma (OPSCC), scheduled to undergo either radiotherapy or chemoradiotherapy as primary treatment in the Beatson West of Scotland Cancer Centre may be suitable for study participation. Suitable patients will be identified at MDT meetings or from the radiotherapy bookings database and approached by the direct clinical care team as they attend for radiotherapy planning appointments. 80 patients will be recruited to the study. Each patient will have at least one target lesion (either lymph node or primary site) for ADC analysis and clinical follow up. MnayMany patients will have 2 or more target lesions. The total number of target lesions is therefore highly likely to be greater than 80.

You may qualify if:

• Histologically confirmed HPV negative SCC oropharynx or patients with HPV positive SCC oropharynx and a significant smoking history
• Stage III or Iva or IVb disease
• Scheduled to undergo radical radiotherapy or chemo radiotherapy as primary treatment
• years of age or older
• Able to give written informed consent
• Patients willing and able to comply with the protocol for the duration of the study
• HPV status: As defined by the Scottish HPV reference laboratory, multiplex assay on Luminex technology Significant smoking history definition: greater than 10 pack years

You may not qualify if:

• Head and neck cancers from sub sites other than oropharynx
• HPV+OPSCC in patients with no significant smoking history (low risk OPSCC)
• Patients receiving cetuximab-radiotherapy
• Confirmed distal metastatic disease (stage IVc)
• Patients who have undergone primary surgery for SCC H\&N, neck dissection alone permitted
• Patients who have received induction chemotherapy prior to definitive treatment
• Patients with contra-indications to MRI scanning
• Contra-indications to MRI:
• As per standard diagnostic imaging protocol - cardiac pacemaker, surgery within 8 weeks, aneurysm clipped/treated, metal fragments in eye, previous cranial surgery, any metal in the body.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Claire Paterson, PhD

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Dearie, BSc (HONS)

CONTACT

+44 (0)141 211 2195; paul.dearie@ggc.scot.nhs.uk

Claire Paterson, PhD

CONTACT

+44 (0)141 301 7428; claire.paterson2@ggc.scot.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 14, 2015
• Study Start: May 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)