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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01242 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This pilot phase II studies how well computed tomography (CT) and positron emission tomography (PET) imaging works in detecting disease in patients undergoing surgery for metastatic colorectal cancer. Diagnostic procedures, such as CT and PET scans, done before and during surgery may help find colorectal cancer and help guide surgery
PRIMARY OBJECTIVES:
I. To determine the feasibility of rigidly (linearly) registering PET to CT images and applying this fused dataset to guide surgery with an image-guided navigation system and a handheld positron probe in order to facilitate disease detection and improve resection accuracy in advanced stage colorectal cancer.
II. To complete development of software for the nonlinear registration of PET and CT datasets.
OUTLINE:
Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive 18 F fludeoxyglucose (FDG) intravenously (IV) 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative PET and CT Scans | Experimental | Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET Scan | Procedure | All patients will receive whole body PET scans (chest-abdomen-pelvis). |
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| Measure | Description | Time Frame |
|---|---|---|
| Detection of Position Accuracy With Handheld Probe on Anatomical Location. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All Adverse Events and Complications | up to 12 months | |
| Tumor Detection | At surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Martin, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17634125 | Result | Sarikaya I, Povoski SP, Al-Saif OH, Kocak E, Bloomston M, Marsh S, Cao Z, Murrey DA, Zhang J, Hall NC, Knopp MV, Martin EW Jr. Combined use of preoperative 18F FDG-PET imaging and intraoperative gamma probe detection for accurate assessment of tumor recurrence in patients with colorectal cancer. World J Surg Oncol. 2007 Jul 16;5:80. doi: 10.1186/1477-7819-5-80. |
| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative PET and CT Scans | Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system. PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis). CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast. fludeoxyglucose F 18: Given IV computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| CT Scan | Procedure | All patients will receive CT scans of the abdomen and pelvis with contrast. |
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| fludeoxyglucose F 18 | Radiation | Given IV |
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| computer-aided detection/diagnosis | Procedure | Undergo computer-aided detection/diagnosis during surgery |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative PET and CT Scans | Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system. PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis). CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast. fludeoxyglucose F 18: Given IV computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean time interval from initial treatment to PET scan | Median | Full Range | months |
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| Mean time interval from PET scan to surgery/GP study | Median | Full Range | days |
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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 | Detection of Position Accuracy With Handheld Probe on Anatomical Location. | number of tumor lesions detected by the probe | Posted | Number | lesions | up to 12 months | Lesions | Participants |
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| Secondary | All Adverse Events and Complications | Posted | Number | patients | up to 12 months |
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| Secondary | Tumor Detection | Posted | Number | lesions detected | At surgery |
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Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
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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 | Preoperative PET and CT Scans | Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system. PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis). CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast. fludeoxyglucose F 18: Given IV computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Martin, MD | The Ohio State University | 614-293-8843 | Edward.Martin@osumc.edu |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| D003936 | Diagnosis, Computer-Assisted |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D003933 | Diagnosis |
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