Breast CancerNCT04363892
Combined Optical and Infrared Imaging for Early Prediction of Erythema During Breast and Chestwall Radiotherapy
A study testing Optical and infrared imaging in people with Breast Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The aim of this study is to develop a computer model, based on photographs and heat images of patients' skin, to provide early prediction of painful reddening of the skin during radiotherapy treatment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Optical and infrared imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2020to 14 Jun 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All female patients referred for adjuvant radiotherapy following breast conserving surgery/mastectomy.
Who cannot join
- Patients with known skin issues (e.g. dermatomyositis, rosacea)
- Patients with excessive risk of skin recurrence, including T4d
- Patients with locally advanced breast cancer.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dalhousie University - Radiation Oncology Department
Halifax, Nova Scotia, B3H 4H7
About this study
Official title: A Prospective Cohort Clinical Trial to Assess the Skin Imaging Spectral and Morphological Changes During Breast Adjuvant Radiotherapy as an Early Predictor of Acute Skin Toxicities
The aim of this study is to develop a computer model, based on photographs and heat images of patients' skin, to provide early prediction of painful reddening of the skin during radiotherapy treatment.
Read the detailed description
There is currently no reliable tool to quantify and detect erythema of the skin during radiotherapy. This side-effect may lead to painful moist desquamation, and eventually permanent delayed side effects like telangiectasia. If such a tool would be available, several interventions could be staged, including (1) the use of steroid cream], (2) the re-simulation and/or re-planning of patients to decrease the skin dose by spreading out the entrance of the beams, (3) adjusting or eliminating the use of bolus on the skin surface (which boosts superficial dose) or (4) the use of other treatment techniques including prone technique.
Given that the dose delivered is not a reliable metric to predict for erythema in a given patient, a new method for monitoring, staging and ultimately predicting skin response is needed. By analyzing images of the skin using both visible and infrared spectral regions, and by carefully converting the information in the images to quantitative metrics, it may be possible to characterize the stage of a patient's response to radiation, and to understand which patients may go on to experience chronic pain, severe burns or other more serious side effects while it is still early enough to intervene.
The proposed research is to develop a software model that will take as input patient skin image data and the patient known clinical outcomes and algorithmically generalize a model to predict a biological response of skin to ionizing radiation for any future patient, after a few initial images.
In the first stage of this study, the data will be aggregated to devise the dose response curve. In later phases, the model will be refined and used for predictive purposes, i.e., once a new patient has begun radiotherapy sessions, their initial response will be quantified, and fed into the model to predict the skin response endpoint after the course of radiation therapy ends. As mentioned, this information could be used to adapt the radiation course and optimize the therapy for the individual, potentially preventing morbidity from overdose, or risk of recurrence from under dose.
- Conditions
- Breast Cancer
- Being tested
- Optical and infrared imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical and infrared imagingOther
Acquiring images (photographs) of the skin
| Study group | Role | What they receive |
|---|---|---|
| Receiving optical and infrared imaging | Experimental | This is the only arm of the study. All patients will have optical and infrared images acquired of skin on the treated and contralateral sides. Receives: Other: Optical and infrared imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the correlation between optical and IR skin imaging and skin toxicity
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week one of radiation treatment
Establish the correlation between optical and IR skin imaging and skin toxicity
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week two of radiation treatment
Establish the correlation between optical and IR skin imaging and skin toxicity
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week three of radiation treatment
Establish the correlation between optical and IR skin imaging and skin toxicity
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week four of radiation treatment
Establish the correlation between optical and IR skin imaging and skin toxicity
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week five of radiation treatment
Secondary outcomes (10)
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week one of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week two of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week three of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week four of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week five of radiation treatment
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week one of radiation treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week five of radiation treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week six, follow-up after treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week seven, follow-up after treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Measured: Week eight, follow-up after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Jul 2020
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Why it stopped: The PI resigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Svatos, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363892
- Sponsor's protocol ID
- RadOnc
- Status last verified
- Aug 2024
- First submitted
- 6 Apr 2020
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Archambeau JO, Pezner R, Wasserman T. Pathophysiology of irradiated skin and breast. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1171-85. doi: 10.1016/0360-3016(94)00423-I.
PubMed 7713781Bentzen SM, Overgaard M. Relationship between early and late normal-tissue injury after postmastectomy radiotherapy. Radiother Oncol. 1991 Mar;20(3):159-65. doi: 10.1016/0167-8140(91)90092-u.
PubMed 1852907Pignol JP, Vu TT, Mitera G, Bosnic S, Verkooijen HM, Truong P. Prospective evaluation of severe skin toxicity and pain during postmastectomy radiation therapy. Int J Radiat Oncol Biol Phys. 2015 Jan 1;91(1):157-64. doi: 10.1016/j.ijrobp.2014.09.022.
PubMed 25835623Pignol JP, Olivotto I, Rakovitch E, Gardner S, Sixel K, Beckham W, Vu TT, Truong P, Ackerman I, Paszat L. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008 May 1;26(13):2085-92. doi: 10.1200/JCO.2007.15.2488. Epub 2008 Feb 19.
PubMed 18285602Pignol JP, Truong P, Rakovitch E, Sattler MG, Whelan TJ, Olivotto IA. Ten years results of the Canadian breast intensity modulated radiation therapy (IMRT) randomized controlled trial. Radiother Oncol. 2016 Dec;121(3):414-419. doi: 10.1016/j.radonc.2016.08.021. Epub 2016 Sep 13.
PubMed 27637858Ishiyama H, Niino K, Hosoya T, Hayakawa K. Results of a questionnaire survey for symptom of late complications caused by radiotherapy in breast conserving therapy. Breast Cancer. 2006;13(2):197-201. doi: 10.2325/jbcs.13.197.
PubMed 16755117Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
PubMed 12393820Formenti SC, Gidea-Addeo D, Goldberg JD, Roses DF, Guth A, Rosenstein BS, DeWyngaert KJ. Phase I-II trial of prone accelerated intensity modulated radiation therapy to the breast to optimally spare normal tissue. J Clin Oncol. 2007 Jun 1;25(16):2236-42. doi: 10.1200/JCO.2006.09.1041. Epub 2007 Apr 30.
PubMed 17470849
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Clinical Trial to Assess the Skin Imaging Spectral and Morphological Changes During Breast Adjuvant Radiotherapy as an Early Predictor of Acute Skin Toxicities
- ClinicalTrials.gov ID
- NCT04363892
- Acronym / sponsor ID
- RadOnc
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI resigned
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 27 Apr 2020 (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.
The aim of this study is to develop a computer model, based on photographs and heat images of patients' skin, to provide early prediction of painful reddening of the skin during radiotherapy treatment.
Detailed description
There is currently no reliable tool to quantify and detect erythema of the skin during radiotherapy. This side-effect may lead to painful moist desquamation, and eventually permanent delayed side effects like telangiectasia. If such a tool would be available, several interventions could be staged, including (1) the use of steroid cream], (2) the re-simulation and/or re-planning of patients to decrease the skin dose by spreading out the entrance of the beams, (3) adjusting or eliminating the use of bolus on the skin surface (which boosts superficial dose) or (4) the use of other treatment techniques including prone technique.
Given that the dose delivered is not a reliable metric to predict for erythema in a given patient, a new method for monitoring, staging and ultimately predicting skin response is needed. By analyzing images of the skin using both visible and infrared spectral regions, and by carefully converting the information in the images to quantitative metrics, it may be possible to characterize the stage of a patient's response to radiation, and to understand which patients may go on to experience chronic pain, severe burns or other more serious side effects while it is still early enough to intervene.
The proposed research is to develop a software model that will take as input patient skin image data and the patient known clinical outcomes and algorithmically generalize a model to predict a biological response of skin to ionizing radiation for any future patient, after a few initial images.
In the first stage of this study, the data will be aggregated to devise the dose response curve. In later phases, the model will be refined and used for predictive purposes, i.e., once a new patient has begun radiotherapy sessions, their initial response will be quantified, and fed into the model to predict the skin response endpoint after the course of radiation therapy ends. As mentioned, this information could be used to adapt the radiation course and optimize the therapy for the individual, potentially preventing morbidity from overdose, or risk of recurrence from under dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving optical and infrared imaging | Experimental | Other: Optical and infrared imagingThis is the only arm of the study. All patients will have optical and infrared images acquired of skin on the treated and contralateral sides. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All female patients referred for adjuvant radiotherapy following breast conserving surgery/mastectomy.
Key exclusion criteria (3 listed)
- Patients with known skin issues (e.g. dermatomyositis, rosacea)
- Patients with excessive risk of skin recurrence, including T4d
- Patients with locally advanced breast cancer.
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 |
|---|---|---|
| Optical and infrared imagingAcquiring images (photographs) of the skin | Other | Receiving optical and infrared imaging |
Primary outcome
Establish the correlation between optical and IR skin imaging and skin toxicity
Time frame: Week one of radiation treatment
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Establish the correlation between optical and IR skin imaging and skin toxicity
Time frame: Week two of radiation treatment
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Establish the correlation between optical and IR skin imaging and skin toxicity
Time frame: Week three of radiation treatment
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Establish the correlation between optical and IR skin imaging and skin toxicity
Time frame: Week four of radiation treatment
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
Establish the correlation between optical and IR skin imaging and skin toxicity
Time frame: Week five of radiation treatment
Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.
10 secondary outcomes
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Time frame: Week one of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Time frame: Week two of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Time frame: Week three of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Time frame: Week four of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
Time frame: Week five of radiation treatment
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
Time frame: Week one of radiation treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
Time frame: Week five of radiation treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
Time frame: Week six, follow-up after treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
Time frame: Week seven, follow-up after treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).
Time frame: Week eight, follow-up after treatment.
Results and safety
The study was stopped early (reason given: The PI resigned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 7713781Archambeau JO, Pezner R, Wasserman T. Pathophysiology of irradiated skin and breast. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1171-85. doi: 10.1016/0360-3016(94)00423-I.
- Background: PubMed 1852907Bentzen SM, Overgaard M. Relationship between early and late normal-tissue injury after postmastectomy radiotherapy. Radiother Oncol. 1991 Mar;20(3):159-65. doi: 10.1016/0167-8140(91)90092-u.
- Background: PubMed 25835623Pignol JP, Vu TT, Mitera G, Bosnic S, Verkooijen HM, Truong P. Prospective evaluation of severe skin toxicity and pain during postmastectomy radiation therapy. Int J Radiat Oncol Biol Phys. 2015 Jan 1;91(1):157-64. doi: 10.1016/j.ijrobp.2014.09.022.
- Background: PubMed 18285602Pignol JP, Olivotto I, Rakovitch E, Gardner S, Sixel K, Beckham W, Vu TT, Truong P, Ackerman I, Paszat L. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008 May 1;26(13):2085-92. doi: 10.1200/JCO.2007.15.2488. Epub 2008 Feb 19.
- Background: PubMed 27637858Pignol JP, Truong P, Rakovitch E, Sattler MG, Whelan TJ, Olivotto IA. Ten years results of the Canadian breast intensity modulated radiation therapy (IMRT) randomized controlled trial. Radiother Oncol. 2016 Dec;121(3):414-419. doi: 10.1016/j.radonc.2016.08.021. Epub 2016 Sep 13.
- Background: PubMed 16755117Ishiyama H, Niino K, Hosoya T, Hayakawa K. Results of a questionnaire survey for symptom of late complications caused by radiotherapy in breast conserving therapy. Breast Cancer. 2006;13(2):197-201. doi: 10.2325/jbcs.13.197.
- Background: PubMed 12393820Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
- Background: PubMed 17470849Formenti SC, Gidea-Addeo D, Goldberg JD, Roses DF, Guth A, Rosenstein BS, DeWyngaert KJ. Phase I-II trial of prone accelerated intensity modulated radiation therapy to the breast to optimally spare normal tissue. J Clin Oncol. 2007 Jun 1;25(16):2236-42. doi: 10.1200/JCO.2006.09.1041. Epub 2007 Apr 30.
- Individual participant dataSharing planned: Yes
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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.
Michele Svatos, PhD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical and infrared imaging in people with Breast Cancer, run by Nova Scotia Health Authority 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Aug 2024. 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 was stopped early (reason given: The PI resigned). Results are not available in the source record.
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?
Establish the correlation between optical and IR skin imaging and skin toxicity (time frame: Week one of radiation treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363892, which also lists 8 linked publications.
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 21 Aug 2024.