Trial Outcomes & Findings for 2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer (NCT NCT01821105)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

up to 12 months

Results posted on

2016-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preoperative PET and CT Scans n=21 Participants 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
Age, Continuous	54 years n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Region of Enrollment United States	21 participants n=99 Participants
Mean time interval from initial treatment to PET scan	42 months n=99 Participants
Mean time interval from PET scan to surgery/GP study	16 days n=99 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: number of tumor lesions detected by the probe

Outcome measures

Outcome measures
Measure	Preoperative PET and CT Scans n=45 Lesions 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
Detection of Position Accuracy With Handheld Probe on Anatomical Location. true postive	35 lesions
Detection of Position Accuracy With Handheld Probe on Anatomical Location. false positive	8 lesions
Detection of Position Accuracy With Handheld Probe on Anatomical Location. not evaluable	2 lesions

SECONDARY outcome

Timeframe: up to 12 months

Outcome measures

Outcome measures
Measure	Preoperative PET and CT Scans n=21 Participants 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
All Adverse Events and Complications	0 patients

SECONDARY outcome

Timeframe: At surgery

Outcome measures

Outcome measures
Measure	Preoperative PET and CT Scans n=21 Participants 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
Tumor Detection	48 lesions detected

Adverse Events

Preoperative PET and CT Scans

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward Martin, MD

The Ohio State University

Phone: 614-293-8843

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place