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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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In this research study, the investigators are evaluating whether ammonia PET scans or FDG PET perfusion scans are more useful in helping radiologists determine whether liver tumors were successfully destroyed by the heating or freezing procedures (ablations) than other scans currently available to radiologists, such as CT scans and MRI scans.
The currently available scan (usually a CT scan with contrast dye) is not always effective in showing how completely the tumor has been destroyed. The ammonia PET scan is a different way of looking at how much tumor has been destroyed. This study will compare the standard scan (CT scan) with the ammonia PET scan.
The plan for this study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia or F-18 fluorodeoxyglucose to image liver perfusion with a PET scanner is the research portion of the procedure. The patient will receive one or two doses of N-13 ammonia (10 mCi (millicurie)/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only. The ammonia perfusion scan will not be used to change or modify the ablation procedure.
After the screening procedures confirm that that the participant is eligible to participate in the research study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-13 ammonia to image liver PET perfusion | Experimental | This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-13 ammonia or F-18 fluorodeoxyglucose | Diagnostic Test | PET tracer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI) | For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? | Percentage of tumors with an inadequate margin on PET that progressed locally? Compare to MRI? | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul B. Shyn, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33606061 | Derived | Shyn PB, Cubre AJ, Catalano PJ, Lee LK, Hyun H, Tuncali K, Seol JG, Levesque VM, Gerbaudo VH, Kapur T, Chao RT, Silverman SG. F-18 FDG perfusion PET: intraprocedural assessment of the liver tumor ablation margin. Abdom Radiol (NY). 2021 Jul;46(7):3437-3447. doi: 10.1007/s00261-021-02970-8. Epub 2021 Feb 19. |
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33 unique participants were enrolled and consented for this study, 6 participants were then excluded from the study.
Thus, the count of subjects is 27. Out of 27 participants, 1 subject participated in both interventions.
33 unique participants were enrolled and consented for this study, 6 participants were then excluded from the study.
Thus, the count of subjects is 27 who were assigned to intervention. Out of 27 participants, 1 subject participated in both interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | N-13 Ammonia to Image Liver PET Perfusion | This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer PET scan: PET scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 27 unique participants and one participant participated twice (in both interventions).
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| ID | Title | Description |
|---|---|---|
| BG000 | N-13 Ammoniaor F-18 Fluorodeoxygl to Image Liver PET Perfusion | This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer PET scan: PET scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI) | For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated. | In this study, the number of tumors were analysed. There 8 participants with 11 tumors that were analysed for N-13 ammonia to image liver PET perfusion and 31 tumors in 20 patients were analysed in F-18 fluorodeoxyglucose to image liver PET perfusion. 1 participant participated in both interventions. Total unique participants 27. | Posted | Count of Units | Tumors | 2 Years | Tumors | Tumors |
|
3 months
27 participants were at risk
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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 | N-13 Ammonia to Image Liver PET Perfusion | This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer PET scan: PET scan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Shyn, MD | Brigham & Women's Hospital INC | 6177326304 | PSHYN@BWH.HARVARD.EDU |
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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 | Mar 1, 2019 | Jan 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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This is a diagnostic imaging study, involving FDA-approved radiopharmaceuticals. Applying a "Phase" to the study is N/A, even though the Study Phase had to be entered above.
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| PET scan | Diagnostic Test | PET scan |
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This single-arm study involves the non-therapeutic administration of a radiopharmaceutical, N-13 ammonia or F-18 fluorodeoxyglucose, one to two doses, during the tumor ablation procedure. The N-13 ammonia perfusion PET scan is a diagnostic imaging test. The tumor ablation procedure is performed according to our standard clinical practice and is not itself a research activity. The use of N-13 ammonia to image liver perfusion with a PET scanner is the research portion of the procedure. The participant will receive one or two IV doses of N-13 ammonia (10 mCi/dose) for intraprocedural assessment of ablation results. Not more than two doses will be administered and one or both doses will be administered on the day of the tumor ablation procedure only N-13 ammonia or F-18 fluorodeoxyglucose: PET tracer PET scan: PET scan |
|
|
| Secondary | Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI? | Percentage of tumors with an inadequate margin on PET that progressed locally? Compare to MRI? | Posted | Number | percentage of tumors | 2 Years | Tumors | Tumors |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
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| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
|
| MRI: % local non-progression per adequate margin |
|