Pancreatic AdenocarcinomaPhase 2NCT03318497
Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
A Phase 2 study testing 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT, Computed Tomography and Positron Emission Tomography in people with Pancreatic Adenocarcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
To assess if percentage change in 18F-FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of neoadjuvant chemotherapy can predict overall survival at 1 and 2 years and progression free survival at 6 months and 1 year in patients with borderline resectable or locally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT, Computed Tomography and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 15 Jun 2021
- Phase
- Phase 2
- 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 with histologically confirmed pancreatic adenocarcinoma (resectable, borderline resectable or locally advanced disease at presentation) are eligible for the study.
- Patients should not have any type of curative or palliative therapy for pancreatic adenocarcinoma before enrolling in the study.
- Patients must be over 18 years old and capable and willing to provide informed consent.
- Patients must have measurable disease (by RECIST 1.1 criteria)
- Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age >70 years).
- Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to FLT (or FDG if for research) PET/CT imaging per institution's standard of care; A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria; Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
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- Medically stable as judged by patient's physician.
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to FLT are NOT eligible.
- Ability to understand and the willingness to sign a written informed consent.
- Patient must be able to lie still for a 20 to 30 minute PET/CT scan.
Who cannot join
- Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study.
- Patient must NOT be pregnant or breast-feeding.
- Patients have no clinical evidence of distant metastatic disease
- Patients must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed.(>200kg or 440lbs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Evaluation of Role of Early Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
To assess if percentage change in 18F-FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of neoadjuvant chemotherapy can predict overall survival at 1 and 2 years and progression free survival at 6 months and 1 year in patients with borderline resectable or locally advanced, pancreatic adenocarcinoma.
Read the detailed description
The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
Visit 1: Patients will have at least one visit with investigator (or investigator designee) prior to the study to review clinical history and prior treatment of pancreatic adenocarcinoma, and to explain the study. Correlative radiology studies including CT, MRI and 18F FDG-PET/CT as per institutional routine clinical care, and any clinically-directed laboratory tests performed as part of staging must be performed within 30 days of the 18F FLT-PET/CT
Visit 2 (Optional): The 18F-FDG-PET/CT may be done as a research scan, if the patient is unable to obtain a clinically-directed 18F-FDG-PET/CT as part of their clinical care or within 30 days of 18F FLT-PET/CT. The research 18F-FDG-PET/CT, in this instance, will be identical in procedure to the institution's clinical 18F-FDG-PET/CT. The blood glucose level will be < 200 mg/dl, before 18F-FDG injection, which is institutional standard clinical protocol. The following additional patient data will be obtained: histological diagnosis of primary and/or metastatic disease, date of diagnosis of primary and metastatic disease, gender, height, weight (for BMI), ECOG score and confirmation of absence of prior treatment.
Visit 3: Day of 18F-FLT-PET/CT: The patient will have an intravenous line placed in the hand or arm, 18F-FLT-PET/CT will be given by 1-2 minute IV push, and the dose administered will be approximately 5 mCi (+/- 20% dose). After approximately 60 +/- 10 minutes of uptake time, the patient will be positioned supine in the PET/CT scanner for standard whole body PET/CT scan from the skull base to mid-thigh. This scan will take approximately 20-30 min. The window from FLT PET/CT baseline study to initiation of chemotherapy should be no more than 30 days.
Visit 4: Day of Interim 18F-FLT-PET/CT: The interim 18F FLT-PET/CT will be performed after the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle. The second 18F-FLT-PET/CT study must be performed on the same scanner as the first 18F FLT-PET/CT and the imaging protocol described in Visit 3 should be closely followed.
Study duration:
Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years following the end of chemotherapy.
.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT, Computed Tomography, Positron Emission Tomography, Laboratory Biomarker Analysis
- Keywords
- Pancreatic adenocarcinoma, 18F-FLT, FLT, Locally advanced pancreatic adenocarcinoma, Borderline resectable pancreatic adenocarcinoma, resectable pancreatic adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLTDrug
Also called FLT, 3'-deoxy-3'-[F-18] fluorothymidine
Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan
Undergo PET/CT
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (Interim FLT PET/CT) | Experimental | The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
* Procedure: Computed Tomography
* Drug: 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT
* Other: Laboratory Biomarker Analysis
* Procedure: Positron Emission Tomography Receives: Drug: 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Summed Standardized Uptake Value (SUVmax) of Lesion After 2 Cycles of Chemotherapy
Change in FLT PET/CT SUV Max after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Max)
Measured: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
Change From Baseline in SUV Peak of Lesion After 2 Cycles of Chemotherapy
Change in FLT PET/CT SUV peak after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Peak)
Measured: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
Change From Baseline in Proliferative Tumor Volume After 2 Cycles Chemotherapy
Change in FLT PET/CT Proliferative tumor volume after 2 cycles of chemotherapy (compared to pre-treatment FLT PET/CT proliferative tumor volume)
Measured: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
1 Year Overall Survival
Proportion of subjects who were alive at 1 year post-treatment is assessed
Measured: Baseline(pre-treatment), until date of first observed death, assessed up to 1 year
2 Year Overall Survival
Proportion of subjects who were alive at 2 years post-treatment is assessed
Measured: Baseline(pre-treatment), until date of first observed death, assessed up to 2 years
Secondary outcomes (2)
6 Months Progression Free Survival
Proportion of subjects who are progression free at 6 months post-treatment is assessed.
Measured: Baseline (pre-treatment), until date of first observed progression, assessed up to 6 months
1 Year Progression Free Survival
Proportion of subjects who are progression free at 1 year post-treatment is assessed.
Measured: Baseline(pre-treatment), until date of first observed progression, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start11 Dec 2017
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
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 AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The interim 18F FLT-PET/CT will be performed after the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle. Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years following the end of chemotherapy.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniella Pinho, University of Texas Southwestern Medical Center
- Investigators
- Daniella Pinho, MD, Principal investigator, UT Soutwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318497
- Sponsor's protocol ID
- STU 012017-029 Protocol V6
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2017
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Evaluation of Role of Early Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03318497
- Acronym / sponsor ID
- STU 012017-029 Protocol V6
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic adenocarcinoma, 18F-FLT, FLT, Locally advanced pancreatic adenocarcinoma, Borderline resectable pancreatic adenocarcinoma, resectable pancreatic adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Posted 8 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess if percentage change in 18F-FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of neoadjuvant chemotherapy can predict overall survival at 1 and 2 years and progression free survival at 6 months and 1 year in patients with borderline resectable or locally advanced, pancreatic adenocarcinoma.
Detailed description
The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
Visit 1: Patients will have at least one visit with investigator (or investigator designee) prior to the study to review clinical history and prior treatment of pancreatic adenocarcinoma, and to explain the study. Correlative radiology studies including CT, MRI and 18F FDG-PET/CT as per institutional routine clinical care, and any clinically-directed laboratory tests performed as part of staging must be performed within 30 days of the 18F FLT-PET/CT
Visit 2 (Optional): The 18F-FDG-PET/CT may be done as a research scan, if the patient is unable to obtain a clinically-directed 18F-FDG-PET/CT as part of their clinical care or within 30 days of 18F FLT-PET/CT. The research 18F-FDG-PET/CT, in this instance, will be identical in procedure to the institution's clinical 18F-FDG-PET/CT. The blood glucose level will be < 200 mg/dl, before 18F-FDG injection, which is institutional standard clinical protocol. The following additional patient data will be obtained: histological diagnosis of primary and/or metastatic disease, date of diagnosis of primary and metastatic disease, gender, height, weight (for BMI), ECOG score and confirmation of absence of prior treatment.
Visit 3: Day of 18F-FLT-PET/CT: The patient will have an intravenous line placed in the hand or arm, 18F-FLT-PET/CT will be given by 1-2 minute IV push, and the dose administered will be approximately 5 mCi (+/- 20% dose). After approximately 60 +/- 10 minutes of uptake time, the patient will be positioned supine in the PET/CT scanner for standard whole body PET/CT scan from the skull base to mid-thigh. This scan will take approximately 20-30 min. The window from FLT PET/CT baseline study to initiation of chemotherapy should be no more than 30 days.
Visit 4: Day of Interim 18F-FLT-PET/CT: The interim 18F FLT-PET/CT will be performed after the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle. The second 18F-FLT-PET/CT study must be performed on the same scanner as the first 18F FLT-PET/CT and the imaging protocol described in Visit 3 should be closely followed.
Study duration:
Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years following the end of chemotherapy.
.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The interim 18F FLT-PET/CT will be performed after the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle. Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years following the end of chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Interim FLT PET/CT) | Experimental | Drug: 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Laboratory Biomarker AnalysisThe experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. * Procedure: Computed Tomography * Drug: 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed pancreatic adenocarcinoma (resectable, borderline resectable or locally advanced disease at presentation) are eligible for the study.
- Patients should not have any type of curative or palliative therapy for pancreatic adenocarcinoma before enrolling in the study.
- Patients must be over 18 years old and capable and willing to provide informed consent.
- Patients must have measurable disease (by RECIST 1.1 criteria)
- Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age >70 years).
Key exclusion criteria (4 listed)
- Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study.
- Patient must NOT be pregnant or breast-feeding.
- Patients have no clinical evidence of distant metastatic disease
- Patients must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed.(>200kg or 440lbs)
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 |
|---|---|---|
| 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLTAlso: FLT, 3'-deoxy-3'-[F-18] fluorothymidineGiven IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up. | Drug | Diagnostic (Interim FLT PET/CT) |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo PET/CT | Procedure or surgery | Diagnostic (Interim FLT PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scanUndergo PET/CT | Procedure or surgery | Diagnostic (Interim FLT PET/CT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (Interim FLT PET/CT) |
Primary outcome
Change From Baseline in Summed Standardized Uptake Value (SUVmax) of Lesion After 2 Cycles of Chemotherapy
Time frame: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
Change in FLT PET/CT SUV Max after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Max)
Change From Baseline in SUV Peak of Lesion After 2 Cycles of Chemotherapy
Time frame: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
Change in FLT PET/CT SUV peak after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Peak)
Change From Baseline in Proliferative Tumor Volume After 2 Cycles Chemotherapy
Time frame: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
Change in FLT PET/CT Proliferative tumor volume after 2 cycles of chemotherapy (compared to pre-treatment FLT PET/CT proliferative tumor volume)
1 Year Overall Survival
Time frame: Baseline(pre-treatment), until date of first observed death, assessed up to 1 year
Proportion of subjects who were alive at 1 year post-treatment is assessed
2 Year Overall Survival
Time frame: Baseline(pre-treatment), until date of first observed death, assessed up to 2 years
Proportion of subjects who were alive at 2 years post-treatment is assessed
2 secondary outcomes
6 Months Progression Free Survival
Time frame: Baseline (pre-treatment), until date of first observed progression, assessed up to 6 months
1 Year Progression Free Survival
Time frame: Baseline(pre-treatment), until date of first observed progression, assessed up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniella Pinho, MD principal investigator
UT Soutwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT, Computed Tomography and Positron Emission Tomography in people with Pancreatic Adenocarcinoma, run by University of Texas Southwestern 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 10 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 8 Nov 2022. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2022). 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?
Change From Baseline in Summed Standardized Uptake Value (SUVmax) of Lesion After 2 Cycles of Chemotherapy (time frame: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)). The study lists 5 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 8 Nov 2022.