Trials / Completed
CompletedNCT01821105
2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer
A 2 Phase Comparison of Pre-operative CT AND PET Images in the Intraoperative Detection of Disease to a Hand-held Probe, and to an Intraoperative CT Scan in Patients Undergoing Surgery for Metastatic Colorectal Cancer.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
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.
Conditions
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Stage IV A Bladder Cancer
- Stage IV A Rectal Cancer
- Stage IV B Colon Cancer
- Stage IV B Rectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | PET Scan | All patients will receive whole body PET scans (chest-abdomen-pelvis). |
| PROCEDURE | CT Scan | All patients will receive CT scans of the abdomen and pelvis with contrast. |
| RADIATION | fludeoxyglucose F 18 | Given IV |
| PROCEDURE | computer-aided detection/diagnosis | Undergo computer-aided detection/diagnosis during surgery |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2009-11-01
- Completion
- 2009-11-01
- First posted
- 2013-03-29
- Last updated
- 2016-03-02
- Results posted
- 2016-02-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01821105. Inclusion in this directory is not an endorsement.