Pancreatic CancerNCT02245217
Multi-Tracer PET Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients
A study testing PET/CT scan to assess treatment efficacy in people with Pancreatic Cancer, run by University of Utah at 1 site in United States.
Trial summary
Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer 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?
- PET/CT scan to assess treatment efficacy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2014to 17 Mar 2016
- 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
- Patients must have either
- histologically/cytologically-confirmed borderline resectable pancreatic cancer and be prescribed neoadjuvant gemcitabine-plus-Abraxane as part of their standard of care
- histologically/cytologically-confirmed locally advanced unresectable pancreatic cancer and be prescribed neoadjuvant gemcitabine-plus-Abraxane as part of their standard of care.
- Diagnostic quality abdominal imaging (CT or MRI) within the past 45 days.
- Patients must be 18 years or older for inclusion in this research study. There is little experience with the safety of fluorine-18 (18F) fluorothymidine (FLT) in children and therefore this radiopharmaceutical should not be used in patients under the age of 18.
- Patients must be willing to lie flat on their back in the PET/CT scanner for up to 2 hours to allow the imaging data to be obtained.
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- Patients must document their willingness to be followed for up to 24 months following enrollment in this imaging trial. By signing informed consent, the patients will document their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database.
- All patients must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
- Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans. The serum pregnancy test must be performed within 48 hours prior to research PET imaging. A negative test will be necessary for such patients to undergo research PET imaging.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Adequate organ function and laboratory parameters as defined laboratory testing.
Who cannot join
- Any prior systemic or investigational therapy for pancreatic cancer.
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals (patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion).
- Patients who are pregnant or lactating or who suspect they might be pregnant. - Serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients known to be HIV positive. This is due to the potential toxicities of [18F]FLT in HIV positive patients.
- Pre-existing sensory neuropathy greater than grade 1.
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- Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer or any other form of cancer from which the patient has been disease-free for 5 years.
- Uncontrolled diabetes or blood glucose greater than 180 mg/dl on the day of the [18F] fluorodeoxyglucose (FDG) PET scan.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social complications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Multi-Tracer Positron Emission Tomography (PET) Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients
Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer
- Conditions
- Pancreatic Cancer
- Being tested
- PET/CT scan to assess treatment efficacy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scan to assess treatment efficacyDevice
| Study group | Role | What they receive |
|---|---|---|
| PET/CT Imaging arm | Experimental | Not described Receives: Device: PET/CT scan to assess treatment efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG Therapeutic Responses to 1 Cycle
The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.
Measured: 1 month
FLT Therapeutic Responses to 1 Cycle
The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.
Measured: 1 month
RECIST 1.1 Therapeutic Responses to 1 Cycle
The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a >30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study start12 Dec 2014
- Primary completion17 Mar 2016
- Study completion17 Mar 2016
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.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245217
- Sponsor's protocol ID
- HCI74163
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2014
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Tracer Positron Emission Tomography (PET) Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT02245217
- Acronym / sponsor ID
- HCI74163
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 12 Dec 2014 (actual)
- Primary completion
- 17 Mar 2016 (actual)
- Study completion
- 17 Mar 2016 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 8 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT Imaging arm | Experimental | Device: PET/CT scan to assess treatment efficacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have either
- Diagnostic quality abdominal imaging (CT or MRI) within the past 45 days.
- Patients must be 18 years or older for inclusion in this research study. There is little experience with the safety of fluorine-18 (18F) fluorothymidine (FLT) in children and therefore this radiopharmaceutical should not be used in patients under the age of 18.
- Patients must be willing to lie flat on their back in the PET/CT scanner for up to 2 hours to allow the imaging data to be obtained.
- Patients must document their willingness to be followed for up to 24 months following enrollment in this imaging trial. By signing informed consent, the patients will document their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database.
Key exclusion criteria (10 listed)
- Any prior systemic or investigational therapy for pancreatic cancer.
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals (patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion).
- Patients who are pregnant or lactating or who suspect they might be pregnant. - Serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients known to be HIV positive. This is due to the potential toxicities of [18F]FLT in HIV positive patients.
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 |
|---|---|---|
| PET/CT scan to assess treatment efficacy | Device | PET/CT Imaging arm |
Primary outcome
FDG Therapeutic Responses to 1 Cycle
Time frame: 1 month
The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.
FLT Therapeutic Responses to 1 Cycle
Time frame: 1 month
The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.
RECIST 1.1 Therapeutic Responses to 1 Cycle
Time frame: 1 month
The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a >30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing PET/CT scan to assess treatment efficacy in people with Pancreatic Cancer, run by University of Utah 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 11 inclusion and 10 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 15 Oct 2021. 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 8 Mar 2018). 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?
FDG Therapeutic Responses to 1 Cycle (time frame: 1 month). 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 15 Oct 2021.