Non-small Cell Lung Cancer Stage IIINCT02053285
Pilot Study of a Novel Type of CT Scan to Assess Treatment Response During Chemoradiotherapy for Stage III Non-Small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer Stage III, run by Rush University Medical Center at 1 site in United States.
Trial summary
Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 20 Feb 2020
- 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 with stage III lung cancer treated with chemoradiotherapy or chemoradiotherapy followed by surgery
Who may be able to join
- Patients aged greater than 18 years with a diagnosis of stage III non-small cell lung cancer.
- Planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection.
- PET-CT study within 4 weeks of next available DECT study.
- Patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm.
- Kidney function sufficient to tolerate iodine-based CT contrast.
- No allergy to iodine-based contrast.
- Ability to understand and the willingness to sign informed consent.
Who cannot join
- Participants with a prior history of thoracic radiotherapy.
- Participants may not be receiving any other study agents.
- Inability to tolerate CT contrast
- Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. These potential risks may also apply to other agents used in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Pilot Study of Dual-Energy Computed Tomography in Stage III Non-Small Cell Lung Cancer
Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. Investigators are therefore using DECT to test whether it can be used on radiation treatment to rapidly assess response to treatment.
- Conditions
- Non-small Cell Lung Cancer Stage III
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the tumor's maximum iodine related attenuation (IRA) from baseline to on-treatment DECT.
This change in the maximum IRA will be compared with the change in the maximum standardized uptake value (SUV max) between baseline PET-CT and follow-up PET-CT at 3 months after treatment. For patients undergoing surgery, this change in the maximum IRA will be compared between patients who have a complete pathologic response, and those patients who do not.
Measured: 0, 1, 3, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053285
- Sponsor's protocol ID
- Dual-Energy Tomogr. | 12051502
- Other IDs
- 12051502
- Status last verified
- Sep 2022
- First submitted
- 23 Jan 2014
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Dual-Energy Computed Tomography in Stage III Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02053285
- Acronym / sponsor ID
- Dual-Energy Tomogr. | 12051502
- Conditions
- Non-small Cell Lung Cancer Stage III
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 3 Feb 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.
Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. Investigators are therefore using DECT to test whether it can be used on radiation treatment to rapidly assess response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage III lung cancer treated with chemoradiotherapy or chemoradiotherapy followed by surgery
Key inclusion criteria (7 listed)
- Patients aged greater than 18 years with a diagnosis of stage III non-small cell lung cancer.
- Planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection.
- PET-CT study within 4 weeks of next available DECT study.
- Patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm.
- Kidney function sufficient to tolerate iodine-based CT contrast.
Key exclusion criteria (4 listed)
- Participants with a prior history of thoracic radiotherapy.
- Participants may not be receiving any other study agents.
- Inability to tolerate CT contrast
- Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. These potential risks may also apply to other agents used in this study.
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
Change in the tumor's maximum iodine related attenuation (IRA) from baseline to on-treatment DECT.
Time frame: 0, 1, 3, 5
This change in the maximum IRA will be compared with the change in the maximum standardized uptake value (SUV max) between baseline PET-CT and follow-up PET-CT at 3 months after treatment. For patients undergoing surgery, this change in the maximum IRA will be compared between patients who have a complete pathologic response, and those patients who do not.
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 23 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non-small Cell Lung Cancer Stage III, run by Rush University Medical Center at 1 site in United States.
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 7 inclusion and 4 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 23 Sep 2022. 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 United States. 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?
Change in the tumor's maximum iodine related attenuation (IRA) from baseline to on-treatment DECT. (time frame: 0, 1, 3, 5). 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 23 Sep 2022.