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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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 | 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 | Baseline(pre-treatment), until date of first observed death, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Months Progression Free Survival | Proportion of subjects who are progression free at 6 months post-treatment is assessed. | Baseline (pre-treatment), until date of first observed progression, assessed up to 6 months |
| 1 Year Progression Free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniella Pinho, MD | UT Soutwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Interim FLT PET/CT) | 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 Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2020 |
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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.
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| Computed Tomography | Procedure | Undergo PET/CT |
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| Positron Emission Tomography | Procedure | Undergo PET/CT |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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Proportion of subjects who are progression free at 1 year post-treatment is assessed.
| Baseline(pre-treatment), until date of first observed progression, assessed up to 1 year |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Interim FLT PET/CT) | 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 Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Only two of the enrolled subjects completed both 18F-FLT-PET/CT scans. | Posted | Mean | Full Range | percentage of SUV Max change | Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days) |
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| Primary | 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) | Data was not collected. | Posted | Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days) |
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| Primary | 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) | Data was not collected | Posted | Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days) |
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| Primary | 1 Year Overall Survival | Proportion of subjects who were alive at 1 year post-treatment is assessed | Posted | Number | percentage of subjects | Baseline(pre-treatment), until date of first observed death, assessed up to 1 year |
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| Primary | 2 Year Overall Survival | Proportion of subjects who were alive at 2 years post-treatment is assessed | Posted | Number | percentage of subjects | Baseline(pre-treatment), until date of first observed death, assessed up to 2 years |
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| Secondary | 6 Months Progression Free Survival | Proportion of subjects who are progression free at 6 months post-treatment is assessed. | 1 subject died and data is not available to be reported | Posted | Number | percentage of subjects | Baseline (pre-treatment), until date of first observed progression, assessed up to 6 months |
| ||||||||||||||||||||||||||||
| Secondary | 1 Year Progression Free Survival | Proportion of subjects who are progression free at 1 year post-treatment is assessed. | 1 subject died and data is not available to be reported | Posted | Number | percentage of subjects | Baseline(pre-treatment), until date of first observed progression, assessed up to 1 year |
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Subjects were monitored for adverse events after injection of the investigational agent and were contacted 24 hours after completion of PET/CT imaging to assess any potentially related adverse events. Subjects' medical records were monitored on a monthly basis to check for any additional adverse events, up 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Interim FLT PET/CT) | 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 Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/CT Laboratory Biomarker Analysis: Correlative studies | 4 | 6 | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelli Key, PhD | UT Southwestern Medical Center | 214-648-8152 | Kelli.Key@UTSouthwestern.edu |
| Sep 9, 2022 |
| Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2020 | Jul 29, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| C002854 | alovudine |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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