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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03665 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial studies multi-tracer positron emission tomography in patients with solid tumors. Diagnostic procedures, such as multi-tracer positron emission tomography, may help measure a patient's response to treatment.
PRIMARY OBJECTIVES:
I. Provide a reliable and validated cadre of positron emission tomography (PET) imaging derived biomarkers that yield a better understanding of: 1) early clinical benefit from various therapeutic agents in investigational and recently approved therapies; 2) efficacy during novel therapeutics in investigational therapeutics and recently approved therapeutics at Huntsman Cancer Institute (HCI); and 3) possible predict prognosis or other long-term outcomes.
II. Reveal a more detailed understanding of: (1) the in vivo biologic mechanisms of various therapeutic drugs in investigational therapies and recently approved therapies at HCI (2) information on why particular functional imaging profiles are seen in treated patients.
III. Reveal a more detailed understanding of how the combination of molecular imaging derived biomarkers will be potentially useful to physicians for decision making and for explanation of efficacy or outcomes for patients with cancer.
IV. Implement and evaluate a new imaging technology for multi-tracer PET imaging of these tracers.
OUTLINE:
Patients undergo PET scans with fludeoxyglucose (FDG) F 18 (18FDG), fluorine F 18 fluorothymidine (FLT), and water (H2O) O-15 (15O) tracers at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (multi-tracer PET scans) | Experimental | Patients undergo Positron Emission Tomography (PET) scans with [F-18]fluorodeoxyglucose and [F-18]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [F-18]fluorodeoxyglucose | Radiation | Undergo PET scans with [F-18]fluorodeoxyglucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| FDG Therapeutic Response | The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). The percent change in the SUVmax for FDG was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax. | 1-2 cycles of treatment - approximately one month |
| FLT Therapeutic Response | The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). The percent change in the SUVmax for FLT was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax. | 1-2 cycles of treatment - approximately one month |
| Standard Therapeutic Response | The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). Percent change in lesion measurements according to standard response criteria for the patient's tumor type were obtained. For brain tumors, Response Assessment in Neuro-Oncology (RANO) criteria were used. Partial Response (PR) was defined as 50% or greater reduction in lesion measurements, Progressive Disease (PD) was 25% or greater increase in measurements, and Stable Disease (SD) was neither PD or PR. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria were used for solid tumors, with PR defined as 30% or greater reduction in measurements, PD was 20% or greater increase in measurements, and SD was all other changes. | 1-2 cycles of treatment - approximately one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Yap, PhD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients: Multi-Tracer PET Scans | Patients undergo Positron Emission Tomography (PET) scans with [F-18]fluorodeoxyglucose and [F-18]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients: Multi-Tracer PET Scans | Patients undergo PET scans with [F-18]fluorodeoxyglucose and [F-18]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | FDG Therapeutic Response | The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). The percent change in the SUVmax for FDG was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax. | Posted | Count of Participants | Participants | 1-2 cycles of treatment - approximately one month |
|
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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 | All Patients: Multi-Tracer PET Scans | Patients undergo PET scans with [F-18]fluorodeoxyglucose and [F-18]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other: Death due to disease pr | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josiah Hawks | Huntsman Cancer Institute Research Compliance Officer | 8015850601 | Josiah.Hawks@hci.utah.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| C002854 | alovudine |
| D009682 | Magnetic Resonance Spectroscopy |
| D014867 | Water |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
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| [F-18]fluorothymidine | Radiation | Undergo PET scans with fluorine [F-18]fluorothymidine |
|
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| Positron Emission Tomography | Procedure | Undergo PET scans with 3 radiotracers (fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15) |
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| Water O-15 | Radiation | Undergo PET scans with water O-15 tracers |
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| years |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | FLT Therapeutic Response | The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). The percent change in the SUVmax for FLT was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax. | Posted | Count of Participants | Participants | 1-2 cycles of treatment - approximately one month |
|
|
|
| Primary | Standard Therapeutic Response | The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). Percent change in lesion measurements according to standard response criteria for the patient's tumor type were obtained. For brain tumors, Response Assessment in Neuro-Oncology (RANO) criteria were used. Partial Response (PR) was defined as 50% or greater reduction in lesion measurements, Progressive Disease (PD) was 25% or greater increase in measurements, and Stable Disease (SD) was neither PD or PR. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria were used for solid tumors, with PR defined as 30% or greater reduction in measurements, PD was 20% or greater increase in measurements, and SD was all other changes. | Posted | Count of Participants | Participants | 1-2 cycles of treatment - approximately one month |
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| 1 |
| 26 |
| 1 |
| 26 |
| 0 |
| 26 |
Death due to disease progression
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |