Recurrent Colon CancerPhase 2NCT01821105
2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer
A Phase 2 study testing PET Scan, CT Scan and fludeoxyglucose F 18 in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV A Bladder Cancer
- What is being tested?
- PET Scan, CT Scan and fludeoxyglucose F 18
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
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.
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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
- Being tested
- PET Scan, CT Scan, fludeoxyglucose F 18, computer-aided detection/diagnosis
- Keywords
- computed tomography, CT scan, positron emission tomography, PET, Metastatic Colorectal Cancer
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Urinary Bladder Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScanProcedure or surgery
All patients will receive whole body PET scans (chest-abdomen-pelvis).
CT ScanProcedure or surgery
All patients will receive CT scans of the abdomen and pelvis with contrast.
fludeoxyglucose F 18Radiation
Also called 18FDG, FDG
Given IV
computer-aided detection/diagnosisProcedure or surgery
Undergo computer-aided detection/diagnosis during surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PET Scan; Procedure: CT Scan; Radiation: fludeoxyglucose F 18; Procedure: computer-aided detection/diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Position Accuracy With Handheld Probe on Anatomical Location.
Measured: up to 12 months
Secondary outcomes (2)
All Adverse Events and Complications
Measured: up to 12 months
Tumor Detection
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startMar 2004
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Colon CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Martin, Ohio State University Comprehensive Cancer Center
- Investigators
- Edward Martin, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821105
- Sponsor's protocol ID
- OSU-0375
- Other IDs
- NCI-2012-01242
- Status last verified
- Feb 2016
- First submitted
- 9 Aug 2012
- Last updated
- 2 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 17634125
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01821105
- Acronym / sponsor ID
- OSU-0375
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Posted 3 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative PET and CT Scans | Experimental | Procedure: PET Scan, Procedure: CT Scan, Radiation: fludeoxyglucose F 18, Procedure: computer-aided detection/diagnosisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET ScanAll patients will receive whole body PET scans (chest-abdomen-pelvis). | Procedure or surgery | Preoperative PET and CT Scans |
| CT ScanAll patients will receive CT scans of the abdomen and pelvis with contrast. | Procedure or surgery | Preoperative PET and CT Scans |
| fludeoxyglucose F 18Also: 18FDG, FDGGiven IV | Radiation | Preoperative PET and CT Scans |
| computer-aided detection/diagnosisUndergo computer-aided detection/diagnosis during surgery | Procedure or surgery | Preoperative PET and CT Scans |
Primary outcome
Detection of Position Accuracy With Handheld Probe on Anatomical Location.
Time frame: up to 12 months
2 secondary outcomes
All Adverse Events and Complications
Time frame: up to 12 months
Tumor Detection
Time frame: At surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17634125Sarikaya 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.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Martin, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET Scan, CT Scan and fludeoxyglucose F 18 in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Position Accuracy With Handheld Probe on Anatomical Location. (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.