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

Recurrent Rectal Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821105
• Other study ID #: OSU-0375
• Secondary ID: NCI-2012-01242
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2012
• Last updated: February 3, 2016
• Start date: March 2004
• Est. completion date: November 2009

Study information

• Verified date: February 2016
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Rectal Neoplasms
• 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

Intervention

Procedure:
• 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.

Radiation:
• fludeoxyglucose F 18
Given IV

Procedure:
• computer-aided detection/diagnosis
Undergo computer-aided detection/diagnosis during surgery

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 recur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Position Accuracy With Handheld Probe on Anatomical Location.		up to 12 months	No
Secondary	All Adverse Events and Complications		up to 12 months	Yes
Secondary	Tumor Detection		At surgery	No

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