Pancreatic CancerNCT01986738
A Pilot Trial to Determine the Extent of Inter- and Intra-Treatment Organ Motion Using Active Breathing Control Device (ABC) in Patients With Pancreatic Cancer
An observational study of Pancreatic Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a study to assess the motion of pancreatic tumors during radiation therapy using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Standard Radiation Therapy and Computed Tomography Scan (CT)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2013
- 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: pancreatic cancer patients undergoing radiation treatment with active breathing control will be asked if they would like to participate.
Who may be able to join
- Patients ≥ 18 years of age
- A working diagnosis (with or without histologic confirmation) of pancreatic cancer
- A plan to treat with radiotherapy (or chemoradiotherapy)
- Patients must have fiducial marker(s) endoscopically placed within the pancreas for clinical treatment.
Who cannot join
- Previous abdominal radiotherapy.
- Patients with a history of major abdominal surgery.
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
This is a study to assess the motion of pancreatic tumors during radiation therapy using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device.
- Conditions
- Pancreatic Cancer
- Being tested
- Standard Radiation Therapy, Active Breathing Control Device (ABC), Computed Tomography Scan (CT)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Radiation TherapyRadiation
Radiotherapy will be planned and delivered according to institutional standard of care.
Active Breathing Control Device (ABC)Device
Computed Tomography Scan (CT)Device
| Study group | Role | What they receive |
|---|---|---|
| Radiation Treatment | Patients undergoing standard of care radiation treatment with Active Breathing Control (ABC) Receives: Radiation: Standard Radiation Therapy; Device: Active Breathing Control Device (ABC); Device: Computed Tomography Scan (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance traveled by the pancreatic tumor during radiation treatment using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device
A marker (implanted near the radiation site, prior to treatment, as a point of reference) will be noted in space on an x, y and z plane using a CT scan. The excursion of this marker during treatment will be determined and the distance traveled, as well as the overall vector (distance and magnitude), will be calculated. Later scans will assess changes in the ability to calculate distance traveled and overall vector of travel.
Measured: Weeks -3 to -1, Week 1, Week 3, Week 5
Distance traveled by the pancreatic tumor between radiation treatments using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device
A marker (implanted near the radiation site prior to treatment as a point of reference) will be noted in space on an x, y and z plane on a pre-treatment/planning Computed Tomography (CT) scan. The relative position of the marker on later CT scans will be compared to the pre-treatment/planning scan and the difference in position will be calculated. The change in the position between all CT scans will be calculated for statistical analysis of tumor movement while undergoing treatment with an Active Breathing Control (ABC) Device.
Measured: Week -3 to -1, Week 1, Week 3, Week 5
Secondary outcomes (2)
Probability of surrounding normal tissue being a particular distance from the tumor marker at any time point.
Measured: Week -1 to -3, Week 1, Week 3, Week 5
Assess the impact of the determined treatment margins on the radiation dose to normal tissues and the ability to escalate dose to the tumor using Intensity-Modulated Radiation Therapy (IMRT)
To assess the impact of the determined treatment margins on radiation dose distribution, we will retrospectively recalculate the patient's treatment plan based on the measured motion of the tumor and normal tissue. This new treatment plan will be compared with the original treatment plan. If the new treatment plan suggests normal tissue was exposed to a reduced amount of radiation, multiple treatment plans will be generated to assess the extent to which this reduction will allow for increased tumor dose in the future.
Measured: Analysis will take place after treatment at approximately week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer 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
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Cuneo, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986738
- Sponsor's protocol ID
- UMCC 2011.055
- Other IDs
- HUM00050677
- Status last verified
- Mar 2017
- First submitted
- 29 Oct 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial to Determine the Extent of Inter- and Intra-Treatment Organ Motion Using Active Breathing Control Device (ABC) in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01986738
- Acronym / sponsor ID
- UMCC 2011.055
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Nov 2013 (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.
This is a study to assess the motion of pancreatic tumors during radiation therapy using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Treatment | – | Radiation: Standard Radiation Therapy, Device: Active Breathing Control Device (ABC), Device: Computed Tomography Scan (CT)Patients undergoing standard of care radiation treatment with Active Breathing Control (ABC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pancreatic cancer patients undergoing radiation treatment with active breathing control will be asked if they would like to participate.
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age
- A working diagnosis (with or without histologic confirmation) of pancreatic cancer
- A plan to treat with radiotherapy (or chemoradiotherapy)
- Patients must have fiducial marker(s) endoscopically placed within the pancreas for clinical treatment.
Key exclusion criteria (3 listed)
- Previous abdominal radiotherapy.
- Patients with a history of major abdominal surgery.
- Patients who are pregnant.
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 |
|---|---|---|
| Standard Radiation TherapyRadiotherapy will be planned and delivered according to institutional standard of care. | Radiation | Radiation Treatment |
| Active Breathing Control Device (ABC) | Device | Radiation Treatment |
| Computed Tomography Scan (CT) | Device | Radiation Treatment |
Primary outcome
Distance traveled by the pancreatic tumor during radiation treatment using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device
Time frame: Weeks -3 to -1, Week 1, Week 3, Week 5
A marker (implanted near the radiation site, prior to treatment, as a point of reference) will be noted in space on an x, y and z plane using a CT scan. The excursion of this marker during treatment will be determined and the distance traveled, as well as the overall vector (distance and magnitude), will be calculated. Later scans will assess changes in the ability to calculate distance traveled and overall vector of travel.
Distance traveled by the pancreatic tumor between radiation treatments using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device
Time frame: Week -3 to -1, Week 1, Week 3, Week 5
A marker (implanted near the radiation site prior to treatment as a point of reference) will be noted in space on an x, y and z plane on a pre-treatment/planning Computed Tomography (CT) scan. The relative position of the marker on later CT scans will be compared to the pre-treatment/planning scan and the difference in position will be calculated. The change in the position between all CT scans will be calculated for statistical analysis of tumor movement while undergoing treatment with an Active Breathing Control (ABC) Device.
2 secondary outcomes
Probability of surrounding normal tissue being a particular distance from the tumor marker at any time point.
Time frame: Week -1 to -3, Week 1, Week 3, Week 5
Assess the impact of the determined treatment margins on the radiation dose to normal tissues and the ability to escalate dose to the tumor using Intensity-Modulated Radiation Therapy (IMRT)
Time frame: Analysis will take place after treatment at approximately week 6
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 3 Mar 2017.
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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.
Kyle Cuneo, M.D. principal investigator
University of Michigan Rogel Cancer Center
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 Pancreatic Cancer, run by University of Michigan Rogel Cancer 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 4 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: finished, as of the sponsor's last update on 3 Mar 2017. 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?
Distance traveled by the pancreatic tumor during radiation treatment using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device (time frame: Weeks -3 to -1, Week 1, Week 3, Week 5). The study lists 2 primary outcomes in all. 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 3 Mar 2017.