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
Conditions
Keywords
computed tomography, CT scan, positron emission tomography, PET, Metastatic Colorectal Cancer
Brief 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.
Interventions
PROCEDUREPET Scan
All patients will receive whole body PET scans (chest-abdomen-pelvis).
PROCEDURECT Scan
All patients will receive CT scans of the abdomen and pelvis with contrast.
RADIATIONfludeoxyglucose F 18
Given IV
PROCEDUREcomputer-aided detection/diagnosis
Undergo computer-aided detection/diagnosis during surgery
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically-confirmed colorectal carcinoma and preoperative PET scan with evidence of hypermetabolic lesions suspicious for cancer will be eligible for this study. In cases of primary cancer, there must be a tissue-confirmed diagnosis. In recurrent cases, patients must have clinical evidence by CT or MRI of disease suitable for resection. * Patients must be candidates for clinically indicated surgery. * Patients with recurrent disease may have had prior surgery and/or chemotherapy with no limit to the number of prior therapeutic procedures or chemotherapeutic regimens. * Patients must have a performance status of 0, 1 or 2 by ECOG(Eastern Cooperative Oncology Group)standards. * Patients must give written informed consent including consent to have IV line placed for FDG administration. * Patients must be at least 18 years of age. Children under the age of 18 are excluded from the study due to the rarity of colorectal cancer in children. * Because radiolabeled agents are known to be teratogenic, women of child-bearing potential and men must agree to use an acceptable form of contraception prior to study entry and for the duration of the study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Organ function requirements: Patients must have organ and marrow function adequate to undergo laparotomy. Specifically: * Serum creatinine \< 2.0 mg/dl * Serum bilirubin \< 2.0 mg/dl * AST(aspartate aminotransferase,serum glutamate oxaloacetate transaminase, serum glutamate oxaloacetate transaminase,serum glutamate pyruvate transaminase)\[SGOT\]/ALT\[SGPT\]\<4 times institutional upper limit of normal * Total WBC(white blood cell)\>4,000/mm3 or ANC(absolute neutrophil count)\> 1,500/mm3 * Platelets \> 100,000/mm3 * Hgb \>10g/dl * Patient must have no clinically significant cardiac disease (New York Heart Association Class III/IV); no serious infection requiring treatment with antibiotics; no other serious ill-ness or illness requiring the use of steroids; no clinically significant pulmonary disease or other illness that would contraindicate or increase the risk of complications at surgery. * Fasting blood sugar less than 120 mg/dl
Exclusion criteria
* Patients with active CNS (central nervous system)tumor involvement are ineligible. * Any patient who has retained childbearing potential will not be pregnant or lactating and must use adequate contraception to assure avoidance of conception. * Body size prohibits use of the diagnostic equipment (portable CT scanner). * Tumor burden is so great (as determined by preoperative PET scanning or intraoperative findings) that further surgery is not advised. * If lesions are detected with preoperative CT but not with PET scanning (in other words, all patients will have a positive PET scan as part of the inclusion criteria).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of Position Accuracy With Handheld Probe on Anatomical Location. | up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| All Adverse Events and Complications | up to 12 months |
| Tumor Detection | At surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Preoperative PET and CT Scans |
|---|---|
| Age, Continuous | 54 years |
| Mean time interval from initial treatment to PET scan | 42 months |
| Mean time interval from PET scan to surgery/GP study | 16 days |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Detection of Position Accuracy With Handheld Probe on Anatomical Location.
Time frame: up to 12 months
Population: number of tumor lesions detected by the probe
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preoperative PET and CT Scans | Detection of Position Accuracy With Handheld Probe on Anatomical Location. | true postive | 35 lesions |
| Preoperative PET and CT Scans | Detection of Position Accuracy With Handheld Probe on Anatomical Location. | false positive | 8 lesions |
| Preoperative PET and CT Scans | Detection of Position Accuracy With Handheld Probe on Anatomical Location. | not evaluable | 2 lesions |
Secondary
All Adverse Events and Complications
Time frame: up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preoperative PET and CT Scans | All Adverse Events and Complications | 0 patients |
Secondary
Tumor Detection
Time frame: At surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preoperative PET and CT Scans | Tumor Detection | 48 lesions detected |