Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV A Bladder Cancer | — | UNRESOLVED | — |
| Stage IV A Rectal Cancer | — | UNRESOLVED | — |
| Stage IV B Colon Cancer | — | UNRESOLVED | — |
| Stage IV B Rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computer-aided detection/diagnosis | Procedure | — | UNRESOLVED |
| CT Scan | Procedure | — | UNRESOLVED |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| PET Scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative PET and CT Scans
- description
- 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.
- interventionNames
- Procedure: PET Scan
- Procedure: CT Scan
- Radiation: fludeoxyglucose F 18
- Procedure: computer-aided detection/diagnosis
Primary outcomes (1)
- measure
- Detection of Position Accuracy With Handheld Probe on Anatomical Location.
- timeFrame
- up to 12 months
Secondary outcomes (2)
- measure
- All Adverse Events and Complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTSarikaya 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. PMID 17634125