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

NCT01821105 | Completed Phase 2 Results DMC

• 2 other identifiers: OSU-0375NCI-2012-01242
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

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

Keywords

computed tomography; CT scan; positron emission tomography; PET; Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Detection of Position Accuracy With Handheld Probe on Anatomical Location.

  up to 12 months

Secondary Outcomes (2)

• All Adverse Events and Complications

  up to 12 months

• Tumor Detection

  At surgery

Study Arms (1)

Preoperative PET and CT Scans

EXPERIMENTAL

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.

Procedure: PET Scan; Procedure: CT Scan; Radiation: fludeoxyglucose F 18; Procedure: computer-aided detection/diagnosis

Interventions

PET Scan PROCEDURE

All patients will receive whole body PET scans (chest-abdomen-pelvis).

Preoperative PET and CT Scans

CT Scan PROCEDURE

All patients will receive CT scans of the abdomen and pelvis with contrast.

Preoperative PET and CT Scans

fludeoxyglucose F 18 RADIATION

Given IV

Also known as: 18FDG, FDG

Preoperative PET and CT Scans

computer-aided detection/diagnosis PROCEDURE

Undergo computer-aided detection/diagnosis during surgery

Preoperative PET and CT Scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related 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 recurrence in patients with colorectal cancer. World J Surg Oncol. 2007 Jul 16;5:80. doi: 10.1186/1477-7819-5-80.

  PMID: 17634125 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Urinary Bladder Neoplasms; Colorectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18; Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates; Diagnosis

Results Point of Contact

• Title: Edward Martin, MD
• Organization: The Ohio State University

Edward.Martin@osumc.edu

614-293-8843

Study Officials

• Edward Martin, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: March 29, 2013
• Study Start: March 1, 2004
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 2, 2016
• Results First Posted: February 3, 2016

Record last verified: 2016-02

Locations

US (1)