Pancreatic CancerEarly Phase 1NCT02024997
Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study
A Early Phase 1 study testing Magnetic Resonance Imaging (MRI) in people with Pancreatic Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The overall aim of this study is to investigate a novel "dual instance" planning method to make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment planning. 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?
- Magnetic Resonance Imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2014
- Phase
- Early Phase 1
- 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
Who may be able to join
- Any patient with a biopsy proven diagnosis of malignancy involving the pancreas to be treated with radiation therapy
- Age >18 years
- Ability to understand and the willingness to sign a written informed consent document
- Creatinine or creatinine clearance of <1.5 times the upper limit of normal or >45 mL/min/1.73m2 for patients with creatinine levels above normal. Modification of Diet in Renal Disease (MDRD) formula was used to calculate the creatinine level
Who cannot join
- Patients who are currently receiving any investigational agents
- Unable to undergo MRIs
- Patients with late stage kidney disease or who have had a liver transplant
- Individuals who are allergic to animal dander or have asthma that may be enflamed by proximity to animals will be excluded as the scans will take place in a facility where animal research is also performed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
The overall aim of this study is to investigate a novel "dual instance" planning method to make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment planning.
Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and expiration (EXP) positions and characterize the changes in geometric relationships between the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification of patients who may benefit from the dual instance planning method.
Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single instance breath hold, and the novel dual instance anatomical information. We hypothesize that use of the dual instance method will lead to improved plans, demonstrated by the ability to increase dose to the target, while maintaining the clinically-accepted normal tissue dose constraints.
- Conditions
- Pancreatic Cancer
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- Pancreatic malignancy, Radiation Therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
| Study group | Role | What they receive |
|---|---|---|
| Abdominal MRI | Experimental | Subjects will undergo magnetic resonance imaging (MRI) with contrast. Magnetic resonance (MR)_freebreathing scan will be acquired. MR_inspiration scan will be acquired. MR_expiration scan will be acquired. Receives: Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes
Measured: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
Secondary outcomes (1)
Modeling the feasibility of the dose escalation using respiration induced anatomic changes
Measured: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
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 Cedars-Sinai 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wensha Yang, PhD., Cedars-Sinai Medical Center
- Investigators
- Wensha Yang, Ph.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024997
- Sponsor's protocol ID
- IIT2012-07-YANG-MRIRESP
- Status last verified
- Oct 2014
- First submitted
- 18 Dec 2013
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study
- ClinicalTrials.gov ID
- NCT02024997
- Acronym / sponsor ID
- IIT2012-07-YANG-MRIRESP
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic malignancy, Radiation Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- First posted
- 31 Dec 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.
The overall aim of this study is to investigate a novel "dual instance" planning method to make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment planning.
Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and expiration (EXP) positions and characterize the changes in geometric relationships between the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification of patients who may benefit from the dual instance planning method.
Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single instance breath hold, and the novel dual instance anatomical information. We hypothesize that use of the dual instance method will lead to improved plans, demonstrated by the ability to increase dose to the target, while maintaining the clinically-accepted normal tissue dose constraints.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal MRI | Experimental | Other: Magnetic Resonance Imaging (MRI)Subjects will undergo magnetic resonance imaging (MRI) with contrast. Magnetic resonance (MR)_freebreathing scan will be acquired. MR_inspiration scan will be acquired. MR_expiration scan will be acquired. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient with a biopsy proven diagnosis of malignancy involving the pancreas to be treated with radiation therapy
- Age >18 years
- Ability to understand and the willingness to sign a written informed consent document
- Creatinine or creatinine clearance of <1.5 times the upper limit of normal or >45 mL/min/1.73m2 for patients with creatinine levels above normal. Modification of Diet in Renal Disease (MDRD) formula was used to calculate the creatinine level
Key exclusion criteria (4 listed)
- Patients who are currently receiving any investigational agents
- Unable to undergo MRIs
- Patients with late stage kidney disease or who have had a liver transplant
- Individuals who are allergic to animal dander or have asthma that may be enflamed by proximity to animals will be excluded as the scans will take place in a facility where animal research is also performed.
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | Abdominal MRI |
Primary outcome
Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes
Time frame: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
1 secondary outcome
Modeling the feasibility of the dose escalation using respiration induced anatomic changes
Time frame: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
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 30 Oct 2014.
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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.
Wensha Yang, Ph.D. principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Magnetic Resonance Imaging (MRI) in people with Pancreatic Cancer, run by Cedars-Sinai 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 4 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 30 Oct 2014. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes (time frame: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)). 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 30 Oct 2014.