Radiotherapy Side EffectNCT04013711
Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy
A study testing Thermography in people with Radiotherapy Side Effect and Radiodermatitis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
A significant proportion of patients treated with whole-breast or head and neck radiotherapy will experience skin toxicity, i.e. skin dermatitis, which may lead to erythema, dry desquamation and wet desquamation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiotherapy Side Effect, Radiodermatitis
- What is being tested?
- Thermography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2018to 19 Jul 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed diagnosis of breast cancer (Stage 0-III) or head and neck cancer (all subtypes; stage I - IV) according to American Joint Committee on Cancer staging criteria.
- Subjects must give appropriate written informed consent prior to participation in the study
- Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure.
- Both men and women are eligible for participation
- Subjects must be at least 18 years of age
- Subjects must be receiving radiotherapy:
Show all 9Show fewer
- adjuvant radiotherapy to the whole breast or chest wall, or;
- in the case of head and neck treatment, either as definitive treatment or adjuvantly.
- definitive radiotherapy of the head and neck
Who cannot join
- Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck.
- Patients with very hairy skin surface (this does not permit measuring the heat output)
- Subjects with a current or past medical history of connective tissue disease.
- Subjects who are pregnant or lactating (which usually preclude them from radiotherapy)
- Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment
A significant proportion of patients treated with whole-breast or head and neck radiotherapy will experience skin toxicity, i.e. skin dermatitis, which may lead to erythema, dry desquamation and wet desquamation. It is hypothesized that quantitative thermal imaging can be used to measure radiation-induced skin toxicity.
Read the detailed description
The aim of this study is to use quantitative thermal imaging to evaluate skin toxicity in patients treated with whole-breast or head and neck radiotherapy.
- Conditions
- Radiotherapy Side Effect, Radiodermatitis
- Being tested
- Thermography
- Medical subject headings
- Radiation Injuries, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermographyDiagnostic test
Thermograms will be acquired of both treated and non-treated cancer site for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Thermal Imaging | Experimental | Patients will undergo non-invasive, thermal imaging of their whole breast or head and neck cancer site, during the course of the radiotherapy treatment, at weekly time intervals. Receives: Diagnostic Test: Thermography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature changes in skin during radiotherapy.
To measure the temperature changes in skin during each week of radiation therapy and correlate to radiotherapy treatment time.
Measured: 1 year
Secondary outcomes (1)
Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire)
Measure patient-reported symptoms using a validated questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Aug 2018
- Primary completion30 Dec 2021
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. William Tran, Sunnybrook Health Sciences Centre
- Investigators
- William T Tran, PhD, Principal investigator, Clinician Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013711
- Sponsor's protocol ID
- 187-2018
- Status last verified
- Feb 2022
- First submitted
- 15 Oct 2018
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment
- ClinicalTrials.gov ID
- NCT04013711
- Acronym / sponsor ID
- 187-2018
- Conditions
- Radiotherapy Side Effect, Radiodermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 10 Jul 2019 (actual)
- 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.
A significant proportion of patients treated with whole-breast or head and neck radiotherapy will experience skin toxicity, i.e. skin dermatitis, which may lead to erythema, dry desquamation and wet desquamation. It is hypothesized that quantitative thermal imaging can be used to measure radiation-induced skin toxicity.
Detailed description
The aim of this study is to use quantitative thermal imaging to evaluate skin toxicity in patients treated with whole-breast or head and neck radiotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermal Imaging | Experimental | Diagnostic Test: ThermographyPatients will undergo non-invasive, thermal imaging of their whole breast or head and neck cancer site, during the course of the radiotherapy treatment, at weekly time intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biopsy-confirmed diagnosis of breast cancer (Stage 0-III) or head and neck cancer (all subtypes; stage I - IV) according to American Joint Committee on Cancer staging criteria.
- Subjects must give appropriate written informed consent prior to participation in the study
- Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure.
- Both men and women are eligible for participation
- Subjects must be at least 18 years of age
Key exclusion criteria (5 listed)
- Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck.
- Patients with very hairy skin surface (this does not permit measuring the heat output)
- Subjects with a current or past medical history of connective tissue disease.
- Subjects who are pregnant or lactating (which usually preclude them from radiotherapy)
- Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermographyThermograms will be acquired of both treated and non-treated cancer site for comparison. | Diagnostic test | Thermal Imaging |
Primary outcome
Temperature changes in skin during radiotherapy.
Time frame: 1 year
To measure the temperature changes in skin during each week of radiation therapy and correlate to radiotherapy treatment time.
1 secondary outcome
Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire)
Time frame: 1 year
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 11 Apr 2023.
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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.
William T Tran, PhD principal investigator
Clinician Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermography in people with Radiotherapy Side Effect and Radiodermatitis, run by Sunnybrook Health Sciences Centre 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 9 inclusion and 5 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 11 Apr 2023. 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?
Temperature changes in skin during radiotherapy. (time frame: 1 year). 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 11 Apr 2023.