Pancreatic Ductal AdenocarcinomaNCT04306861
Novel MRI Techniques for Pancreatic Cancer
An observational study of Pancreatic Ductal Adenocarcinoma, run by Beth Israel Deaconess Medical Center.
Trial summary
The purpose of this study is to optimize magnetic resonance imaging (MRI) sequences for imaging pancreatic ductal adenocarcinoma and correlate MRI biomarkers with the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- MRI
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2020to 30 Aug 2022
- 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: Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy.
Who may be able to join
- Adult male or female patient 18 years of age or older;
- Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC);
- Patient qualifying for neoadjuvant chemo-radiation therapy;
- Patient able and willing to participate in the study;
- Patient must sign the informed consent form in order to participate after the nature of the study has been fully explained to them and any questions they might have are adequately answered.
- eGFR levels greater than or equal to 30 mL/min/1.73m2 before contrast administration.
Who cannot join
- Patient previously-received or receiving treatment for PDAC at time of enrollment;
- Inability to understand or follow study instructions
- Diagnosed by a nutritionist with severe malnutrition;
- Unintentional weight loss of 20% or more throughout study;
- BMI of < 18.5;
- Patients with a contraindication to MRI examinations will be excluded from this study.
- Pregnancy
- Estimated Glomerular Filtration Rate (eGFR) levels < 30 mL/min/1.73m2
About this study
Official title: Novel Multi-parametric MRI Techniques for Assessment of Patients With Pancreatic Ductal Adenocarcinoma Before and During Neoadjuvant Therapy
The purpose of this study is to optimize magnetic resonance imaging (MRI) sequences for imaging pancreatic ductal adenocarcinoma and correlate MRI biomarkers with the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response. This study will test magnetic resonance techniques on FDA approved clinical MRI machines in treatment-naïve patients with biopsy-proven PDAC.
Read the detailed description
Specific Aims
- To optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC): Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).
- To measure these MRI biomarkers in 20 treatment-naïve patients with biopsy-proven PDAC who have been referred to the Beth Israel Deaconess Medical Center (BIDMC) Pancreatic Cancer Program for neoadjuvant chemo-radiation therapy (CRT).
- To correlate these MRI biomarkers with histopathology, i.e. the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response.
The investigators hypothesize the following:
- It is feasible to develop dedicated MRI protocols with novel MRI techniques including Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI), and to develop appropriate evaluation methods.
- The implementation of these new protocols and evaluation methods in patients with pancreatic ductal adenocarcinoma (PDAC) provide biomarkers which correlate with histology and outcome in treatment-naïve patients.
- The biomarkers are also predictive of therapy response in patients with PDAC during neoadjuvant chemo-radiation therapy (CRT) and correlate with the expression of the tumor suppressor gene SMAD4.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- MRI
- Keywords
- Imaging, MRI, PDAC, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Baseline contrast-enhanced MRI and 2 follow-up contrast-enhanced MRIs (mid-treatment and treatment completion)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Naïve PDAC Patients | Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC)
Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).
Measured: Study Duration, an average of 1 year
Measure the biomarkers obtained with MRI in treatment-naïve patients with biopsy-proven PDAC
Biomarkers are obtained from the following imaging methods: Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).
Measured: Study Duration, an average of 1 year
Correlate MRI biomarkers with histopathology (the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response).
Biomarkers are obtained from the following imaging methods: Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).
Measured: Study Duration, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start9 Mar 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Why it stopped: Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leo L Tsai, Beth Israel Deaconess Medical Center
- Investigators
- Leo L Tsai, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306861
- Sponsor's protocol ID
- 2019-P-000549
- Status last verified
- Jul 2022
- First submitted
- 22 Nov 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Multi-parametric MRI Techniques for Assessment of Patients With Pancreatic Ductal Adenocarcinoma Before and During Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT04306861
- Acronym / sponsor ID
- 2019-P-000549
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Imaging, MRI, PDAC, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 13 Mar 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 purpose of this study is to optimize magnetic resonance imaging (MRI) sequences for imaging pancreatic ductal adenocarcinoma and correlate MRI biomarkers with the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response. This study will test magnetic resonance techniques on FDA approved clinical MRI machines in treatment-naïve patients with biopsy-proven PDAC.
Detailed description
Specific Aims
- To optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC): Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).
- To measure these MRI biomarkers in 20 treatment-naïve patients with biopsy-proven PDAC who have been referred to the Beth Israel Deaconess Medical Center (BIDMC) Pancreatic Cancer Program for neoadjuvant chemo-radiation therapy (CRT).
- To correlate these MRI biomarkers with histopathology, i.e. the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response.
The investigators hypothesize the following:
- It is feasible to develop dedicated MRI protocols with novel MRI techniques including Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI), and to develop appropriate evaluation methods.
- The implementation of these new protocols and evaluation methods in patients with pancreatic ductal adenocarcinoma (PDAC) provide biomarkers which correlate with histology and outcome in treatment-naïve patients.
- The biomarkers are also predictive of therapy response in patients with PDAC during neoadjuvant chemo-radiation therapy (CRT) and correlate with the expression of the tumor suppressor gene SMAD4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Naïve PDAC Patients | – | Diagnostic Test: MRIPatient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy.
Key inclusion criteria (6 listed)
- Adult male or female patient 18 years of age or older;
- Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC);
- Patient qualifying for neoadjuvant chemo-radiation therapy;
- Patient able and willing to participate in the study;
- Patient must sign the informed consent form in order to participate after the nature of the study has been fully explained to them and any questions they might have are adequately answered.
Key exclusion criteria (8 listed)
- Patient previously-received or receiving treatment for PDAC at time of enrollment;
- Inability to understand or follow study instructions
- Diagnosed by a nutritionist with severe malnutrition;
- Unintentional weight loss of 20% or more throughout study;
- BMI of < 18.5;
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 |
|---|---|---|
| MRIBaseline contrast-enhanced MRI and 2 follow-up contrast-enhanced MRIs (mid-treatment and treatment completion) | Diagnostic test | Treatment Naïve PDAC Patients |
Primary outcome
Optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC)
Time frame: Study Duration, an average of 1 year
Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).
Measure the biomarkers obtained with MRI in treatment-naïve patients with biopsy-proven PDAC
Time frame: Study Duration, an average of 1 year
Biomarkers are obtained from the following imaging methods: Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).
Correlate MRI biomarkers with histopathology (the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response).
Time frame: Study Duration, an average of 1 year
Biomarkers are obtained from the following imaging methods: Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Key Statistics for Pancreatic CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Leo L Tsai, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Beth Israel Deaconess Medical Center.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC) (time frame: Study Duration, an average of 1 year). The study lists 3 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 21 Jul 2022.