Head and Neck Squamous Cell CarcinomaNCT02279459
Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas
An observational study of Head and Neck Squamous Cell Carcinoma, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas (HNSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2015to 15 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, aged 18 years and older with untreated, histologically confirmed head and neck squamous cell carcinoma
Who may be able to join
- 18 years and older
- untreated, histologically confirmed head and neck squamous cell carcinoma
Who cannot join
- paranasal sinus involvement of head and neck squamous cell carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas: Assessing Tumor Perfusion and Prediction of Treatment Outcomes
The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the added benefit of providing functional information that would only be possible with advanced computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission tomography (PET) imaging techniques.
Read the detailed description
Patients with head and/or neck tumors routinely have head and neck imaging completed with a computerized tomography scan, commonly called a CT scan. A CT scan combines a series of x-ray views that are taken from many different angles and uses computer processing to create cross-sectional images inside your body. These cross-sectional images are very thin slices, often less than 1 mm thick and allow the radiologist to examine parts of your tissue very closely.
Dual energy computed tomography (DECT) is a fairly new technology that uses both the normal x-ray and also a second less powerful x-ray to make the images. The Ottawa Hospital has scanners in use that are able to take the images that oncologists typically order for patients and can also be set to obtain DECT images at the same time.
The purpose of this study is to investigate whether DECT images can provide helpful information to better predict how the tumor will respond to treatment and the likely course of head and neck tumors.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients head and neck CT scans performed as standard of care done prior to radiation treatment and approximately 12 weeks following treatment, will be acquired in the dual-energy computed tomography (DECT) mode. Participants will have one additional scan, also in the DECT mode, 2 to 3 weeks after the start of their radiation treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate iodine quantification with the microvascular density in the biopsy specimen
Measured: up to 18 months
Secondary outcomes (1)
Utility of dual-energy computerized tomography obtained during chemoradiation therapy to predict treatment response.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start14 Apr 2015
- Primary completion1 Oct 2018
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Santanu Chakraborty, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279459
- Sponsor's protocol ID
- 20140728-01H
- Status last verified
- Aug 2020
- First submitted
- 28 Oct 2014
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas: Assessing Tumor Perfusion and Prediction of Treatment Outcomes
- ClinicalTrials.gov ID
- NCT02279459
- Acronym / sponsor ID
- 20140728-01H
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the added benefit of providing functional information that would only be possible with advanced computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission tomography (PET) imaging techniques.
Detailed description
Patients with head and/or neck tumors routinely have head and neck imaging completed with a computerized tomography scan, commonly called a CT scan. A CT scan combines a series of x-ray views that are taken from many different angles and uses computer processing to create cross-sectional images inside your body. These cross-sectional images are very thin slices, often less than 1 mm thick and allow the radiologist to examine parts of your tissue very closely.
Dual energy computed tomography (DECT) is a fairly new technology that uses both the normal x-ray and also a second less powerful x-ray to make the images. The Ottawa Hospital has scanners in use that are able to take the images that oncologists typically order for patients and can also be set to obtain DECT images at the same time.
The purpose of this study is to investigate whether DECT images can provide helpful information to better predict how the tumor will respond to treatment and the likely course of head and neck tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Patients head and neck CT scans performed as standard of care done prior to radiation treatment and approximately 12 weeks following treatment, will be acquired in the dual-energy computed tomography (DECT) mode. Participants will have one additional scan, also in the DECT mode, 2 to 3 weeks after the start of their radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, aged 18 years and older with untreated, histologically confirmed head and neck squamous cell carcinoma
Key inclusion criteria (2 listed)
- 18 years and older
- untreated, histologically confirmed head and neck squamous cell carcinoma
Key exclusion criteria (1 listed)
- paranasal sinus involvement of head and neck squamous cell carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlate iodine quantification with the microvascular density in the biopsy specimen
Time frame: up to 18 months
1 secondary outcome
Utility of dual-energy computerized tomography obtained during chemoradiation therapy to predict treatment response.
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santanu Chakraborty, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate iodine quantification with the microvascular density in the biopsy specimen (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.