NCT02678884

Brief Summary

The purpose of this study is to see how useful the information provided from Positron Emission Tomography (PET) scans can be in the actual planning and delivery of radiation treatment to patients who have head and neck cancers. Patients participating in this study, will have (in addition to their routine tests) a PET scan before and during their radiation treatment. Following the intervention, patients will be followed as per standard practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
30mo left

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress83%
Oct 2014Nov 2028

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

14.1 years

First QC Date

November 27, 2014

Last Update Submit

March 12, 2024

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Squamous Cell CarcinomaRadiation therapyHead and Neck Cancers

Outcome Measures

Primary Outcomes (1)

  • Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy.

    ~ 2 years

Secondary Outcomes (1)

  • Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy .

    ~ 2 years

Study Arms (1)

HNSCC Patients receiving RT

EXPERIMENTAL
Drug: 18-F FDG

Interventions

18-F FDGDRUG

All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.

HNSCC Patients receiving RT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-nasopharynx head and neck mucosal squamous cell carcinoma
  • Radiologically evident gross disease
  • Radiotherapy alone for curative intent
  • Age equal to or more than 18 years old
  • To be eligible for the second study PET-CT scan: FDG avid tumour (or minimum SUV of 2.5) on the first study PET-CT scan

You may not qualify if:

  • Nasopharynx cancer
  • H\&N SCC skin
  • Distant metastases (already known or if found on baseline CT-thorax)
  • Prior malignancy within the last 5 years (exclude non-H\&N SCC, BCC skin)
  • Prior chemotherapy within the last 5 years or concurrent chemotherapy/EGFR inhibitors
  • Prior head and neck radiotherapy
  • Inability to lie supine for study duration
  • Pregnancy
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • John J Kim, MD

    The Princess Margaret Cancer Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John J Kim, MD

CONTACT

416 946 4501John.kim@rmp.uhn.on.ca

Stephen Breen, PhD

CONTACT

416 946 4501Stephen.Breen@rmp.uhn.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

February 10, 2016

Study Start

October 1, 2014

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

CA(1)