Pancreatic CancerNCT01015820
Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
A study testing EGD with EUS and 4D-ELF in people with Pancreatic Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Pancreatic cancer is the fourth leading cause of cancer death in the United States and is associated with a poor prognosis. The average life expectancy after diagnosis is approximately 5 to 8 months. At present, successful surgical resection is the only curative therapy that can improve long-term survival. 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?
- EGD with EUS and 4D-ELF
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or older.
- Informed written consent.
- Patient scheduled for previously planned EGD with upper EUS
- Patients with known adenocarcinoma of the pancreas included in the cancer group
- Patients with abdominal imaging studies (e.g., CT abdomen or MRI abdomen) negative for malignancy in past 5 years included in the control group.
Who cannot join
- Unable to obtain biopsy specimen or fine-needle aspiration results of the pancreas lesion (e.g., coagulation disorder, inadequate sample)
- Presence of malignant lesion in the pancreas or duodenum other than pancreas adenocarcinoma (e.g., neuroendocrine tumor, gastrointestinal stromal tumor)
- Known familial disorder with high risk of pancreas cancer development (e.g., familial adenomatous polyposis syndrome, hereditary non-polyposis colorectal cancer syndrome, juvenile polyposis syndrome)
- Significant family history of pancreatic cancer (at least one first degree relative with pancreatic cancer)
- Presence of premalignant lesions (e.g., duodenal adenoma, pancreas intraductal papillary mucinous neoplasm)
- Active visible inflammation/ulcer in the stomach or the duodenum
- Patients with known chronic pancreatitis were excluded from cancer group. Chronic pancreatitis patients were allowed to be included in the control group only.
- Known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer death in the United States and is associated with a poor prognosis. The average life expectancy after diagnosis is approximately 5 to 8 months. At present, successful surgical resection is the only curative therapy that can improve long-term survival. However, it can be achieved only when a tumor is detected at an early stage. Unfortunately, due to non-specific symptoms associated with pancreatic cancer, it is commonly detected in the later stages of the disease.
The investigators hypothesized that pancreatic cancer could be detected by measuring the changes in the early increase in blood supply (EIBS) found in the surrounding normal-appearing duodenal tissue. The investigators tested a device called Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF). The device used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA allowed the use of this device in this research study.
Read the detailed description
According to field effect theory, by detecting microvasculature changes in the early increase of blood supply in the surrounding tissue neoplastic lesions can be identified from a distance.
The objective of this study was to determine the feasibility and efficacy of a fiberoptic probe containing novel Polarization Gating Spectroscopy (PGS) technology to identify patients with pancreatic adenocarcinoma (PAC) by field effect theory. EIBS markers, deoxyhemoglobin concentration (DHb), and average blood vessel radius (BVR) were evaluated in patients with PAC versus controls.
During the subjects' esophagogastroduodenoscopy (EGD) with upper endoscopic ultrasound (EUS), the new optic probe was inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope was withdrawn, the light optic probe was used to examine approximately 5 sections of the small bowel: 1) directly on the ampulla, 2) approximately 5 mm proximal from the ampulla, 3) approximately 5 mm distal from the ampulla, 4) 1 cm proximal from the ampulla, and 5) 1 cm distal from the ampulla. Spectroscopy measurements were obtained four times in each of these five peri-ampullary locations. The rest of the EGD and upper EUS endoscopy procedures were then completed as clinically indicated. During the procedure, all visualized mucosal abnormalities were recorded and photographed.
- Conditions
- Pancreatic Cancer
- Being tested
- EGD with EUS, 4D-ELF
- Keywords
- Pancreatic Cancer, Duodenum, Spectroscopy, Fiberoptic probe, 4D-ELF
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGD with EUSProcedure or surgery
EUS was performed in order to measure blood flow in duodenum.
4D-ELFDevice
During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
| Study group | Role | What they receive |
|---|---|---|
| Cancer group | Experimental | Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device. Receives: Procedure: EGD with EUS; Device: 4D-ELF |
| Control group | Other | Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device. Receives: Procedure: EGD with EUS; Device: 4D-ELF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deoxyhemoglobin Concentration (DHb)
Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.
Measured: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
Mean Blood Vessel Radius (BVR)
BVR serves as a marker for early increase of blood supply (EIBS).
Measured: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Michael Wallace, Mayo Clinic
- Investigators
- Michael B. Wallace, MD MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015820
- Sponsor's protocol ID
- 09-002596
- Other IDs
- R01CA128641, R01CA156186, R01EB003682, U01CA111257, CBET-1240416
- Status last verified
- Jul 2014
- First submitted
- 12 Nov 2009
- Last updated
- 16 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Patel M, Gomes A, Ruderman S, Hardee D, Crespo S, Raimondo M, Woodward T, Backman V, Roy H, Wallace M. Polarization gating spectroscopy of normal-appearing duodenal mucosa to detect pancreatic cancer. Gastrointest Endosc. 2014 Nov;80(5):786-93.e1-2. doi: 10.1016/j.gie.2014.03.031. Epub 2014 May 24.
PubMed 24861243
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01015820
- Acronym / sponsor ID
- 09-002596
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Duodenum, Spectroscopy, Fiberoptic probe, 4D-ELF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Northwestern University, National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Posted 2 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer is the fourth leading cause of cancer death in the United States and is associated with a poor prognosis. The average life expectancy after diagnosis is approximately 5 to 8 months. At present, successful surgical resection is the only curative therapy that can improve long-term survival. However, it can be achieved only when a tumor is detected at an early stage. Unfortunately, due to non-specific symptoms associated with pancreatic cancer, it is commonly detected in the later stages of the disease.
The investigators hypothesized that pancreatic cancer could be detected by measuring the changes in the early increase in blood supply (EIBS) found in the surrounding normal-appearing duodenal tissue. The investigators tested a device called Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF). The device used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA allowed the use of this device in this research study.
Detailed description
According to field effect theory, by detecting microvasculature changes in the early increase of blood supply in the surrounding tissue neoplastic lesions can be identified from a distance.
The objective of this study was to determine the feasibility and efficacy of a fiberoptic probe containing novel Polarization Gating Spectroscopy (PGS) technology to identify patients with pancreatic adenocarcinoma (PAC) by field effect theory. EIBS markers, deoxyhemoglobin concentration (DHb), and average blood vessel radius (BVR) were evaluated in patients with PAC versus controls.
During the subjects' esophagogastroduodenoscopy (EGD) with upper endoscopic ultrasound (EUS), the new optic probe was inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope was withdrawn, the light optic probe was used to examine approximately 5 sections of the small bowel: 1) directly on the ampulla, 2) approximately 5 mm proximal from the ampulla, 3) approximately 5 mm distal from the ampulla, 4) 1 cm proximal from the ampulla, and 5) 1 cm distal from the ampulla. Spectroscopy measurements were obtained four times in each of these five peri-ampullary locations. The rest of the EGD and upper EUS endoscopy procedures were then completed as clinically indicated. During the procedure, all visualized mucosal abnormalities were recorded and photographed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer group | Experimental | Procedure: EGD with EUS, Device: 4D-ELFParticipants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device. |
| Control group | Other | Procedure: EGD with EUS, Device: 4D-ELFParticipants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Informed written consent.
- Patient scheduled for previously planned EGD with upper EUS
- Patients with known adenocarcinoma of the pancreas included in the cancer group
- Patients with abdominal imaging studies (e.g., CT abdomen or MRI abdomen) negative for malignancy in past 5 years included in the control group.
Key exclusion criteria (8 listed)
- Unable to obtain biopsy specimen or fine-needle aspiration results of the pancreas lesion (e.g., coagulation disorder, inadequate sample)
- Presence of malignant lesion in the pancreas or duodenum other than pancreas adenocarcinoma (e.g., neuroendocrine tumor, gastrointestinal stromal tumor)
- Known familial disorder with high risk of pancreas cancer development (e.g., familial adenomatous polyposis syndrome, hereditary non-polyposis colorectal cancer syndrome, juvenile polyposis syndrome)
- Significant family history of pancreatic cancer (at least one first degree relative with pancreatic cancer)
- Presence of premalignant lesions (e.g., duodenal adenoma, pancreas intraductal papillary mucinous neoplasm)
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 |
|---|---|---|
| EGD with EUSEUS was performed in order to measure blood flow in duodenum. | Procedure or surgery | Cancer group, Control group |
| 4D-ELFDuring the EUS, blood flow was measured in the duodenum with the 4D-ELF device. | Device | Cancer group, Control group |
Primary outcome
Deoxyhemoglobin Concentration (DHb)
Time frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.
Mean Blood Vessel Radius (BVR)
Time frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation
BVR serves as a marker for early increase of blood supply (EIBS).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24861243Patel M, Gomes A, Ruderman S, Hardee D, Crespo S, Raimondo M, Woodward T, Backman V, Roy H, Wallace M. Polarization gating spectroscopy of normal-appearing duodenal mucosa to detect pancreatic cancer. Gastrointest Endosc. 2014 Nov;80(5):786-93.e1-2. doi: 10.1016/j.gie.2014.03.031. Epub 2014 May 24.
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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.
Michael B. Wallace, MD MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EGD with EUS and 4D-ELF in people with Pancreatic Cancer, run by Mayo Clinic 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 5 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: finished, as of the sponsor's last update on 16 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Deoxyhemoglobin Concentration (DHb) (time frame: Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation). 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?
On the ClinicalTrials.gov record for NCT01015820, which also lists 1 linked publication.
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 16 Jul 2014.