Rectal CancerPhase 2NCT01525056
Rectal Cancer: Local Staging, Re-staging and Assessment of Lymph Nodes Using Pet-Ct, CT-Perfusion and 3T MRI
A Phase 2 study testing ct and mri scans, ct, mri and pet scan and ct, mri and pet scans in people with Rectal Cancer, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the accuracy of Positron emission tomography, Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal cancer following neoadjuvant chemoradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- ct and mri scans, ct, mri and pet scan and ct, mri and pet scans
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Rectal cancer, stage T2, T3, T4
Who cannot join
- Rectal cancer, stage T1 or metastatic
- Non-rectal primary cancer invading the rectum
- Mucinous histology
- Patient is initially, or becomes a non-surgical candidate during the course of the study
- Hip prosthesis (affects PET-CT image processing)
- Allergy to CT contrast or patients with impaired renal function, defined as estimated glomerular filtrate rate (eGFR)< 30 ml/min
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- Prior radiotherapy to the region of the study that would result in overlap of radiation fields
- Contraindications to MRI
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rectal Cancer: Local Staging, Re-staging and Assessment of Lymph Node Metastases Using PET-CT, CT-Perfusion and 3T MRI: A Prospective Feasibility Study
The purpose of this study is to evaluate the accuracy of Positron emission tomography, Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal cancer following neoadjuvant chemoradiation. The restaging result obtained by these imaging studies will be compared to standard imaging studies and the histopathology of the surgical specimen. We hypothesize that these 3 imaging modalities will detect lymph node metastases pretreatment better than standard pretreatment scans and will better determine the degree of response of the primary rectal tumor to preoperative chemoradiation.
Read the detailed description
Patient Recruitment:
30 consecutive patients with histologically-proven, non-mucinous rectal cancer will be recruited and stratified into three separate groups as follows:
- T2 tumors (requiring only surgery)
- Early T3 tumors (requiring preoperative standard course radiation therapy)
- Advanced T3 and T4 tumors (requiring preoperative chemoradiation)
Study Protocol:
The pretreatment imaging studies will be performed with a 3T MRI pelvis,PET-CT and CT-Perfusion of the pelvis. The patient will then receive standard treatment consisting of surgery,radiation therapy or a course of neoadjuvant chemoradiation.For patients with T3 and T4 tumors, repeat imaging using all three modalities outlined above will be performed post-treatment.
Histopathology \& data analysis
MRI Protocol:
All patients will be examined on a 3-T MRI unit (Siemens Medical, Germany) at St. Joseph's Hospital, London.
The MRI protocol is as follows:
- Buscopan 40 mg IM/IV prior to study
- Axial T2 TSE of the entire pelvis (aortic bifurcation to pubic symphysis)
- Sagittal T2 TSE (240 cm FOV) for detection of the rectal tumor
- Axial oblique T2 TSE (220 cm FOV) perpendicular to the rectal tumor
- 3 mm slice thickness
- Coronal T2 TSE (220 cm FOV)
- Axial DWI (B values 0, 500, 1000)
- ADC map
Unless otherwise specified, slice thickness is 4mm. Technique is free-breathing; no bowel preparation, intraluminal or intravascular contrast agents are administered.
PET-CT Protocol:
- Patient fasts for 6-12 hours prior to study, depending on timing of scan
- Patients to be scanned in the morning will fast overnight; those being scanned in the afternoon will fast for 6 hours following a light breakfast.
- Blood sugar level measurement prior to study (should be less than 11 mmol/L). Insulin dependent diabetics are scanned in the early afternoon following a light breakfast and routine morning insulin.
- Exclude pregnancy with urine/serum hCG
- Intravenous injection of 5MBq/kg of F-18 FDG)
- Intravenous injection of 20 mg Lasix, 10 minutes following F-18 FDG injection
- IV hydration with 250-500 mL of saline
- 60 minutes post-injection, acquire non contrast CT and positron emission tomography imaging of the pelvis
CT Perfusion Protocol:
All patients will undergo CT Perfusion with a 64-slice CT scanner (Discovery CT750 HD, GE Healthcare) at St. Joseph's Health Care, London.
The protocol is as follows:
- Preliminary non-contrast 2.5-mm-thick helical CT of the pelvic region (from the aortic bifurcation to the symphysis pubis) with free-breathing to locate a 8-cm section of the rectal tumor that was imaged in the MRI study.
- Prescribe a CT Perfusion study using the axial shuttle mode on the 8-cm section identified above. The perfusion study consists of two phases. The selected pelvic section is scanned every 2.8 s for 64.4 s (24 times) in the first phase and every 15 s for the next 120 s (8 times) in the second phase. The total duration of scanning is 184.4 s. The scanning parameters for both phases are: 120 kVp, 125 mA, 0.4 s rotation period, and 5 mm thick slices. All dynamic images will be reconstructed with adaptive statistical iterative reconstruction (ASIR) technique to reduce noise.
- Contrast injected at a rate of 3-4 ml/s will start at the same as the two-phase scanning, to allow for acquisition of 3-4 baseline volumes (before contrast arrives in the pelvis).
- Free-breathing is allowed during scanning.
- Contrast dose is 0.8ml/kg of body weight up to maximum of 70 ml of contrast at a concentration of 370 mg iodine/ml.
- The acquired dynamic contrast enhanced (DCE) images will be analyzed by CT Perfusion (GE Healthcare) to determine blood flow, blood volume, mean transit time and capillary permeability surface area of the tumor.
Surgical Resection and histopathological examination:
- Total mesorectal excision as per standardized surgical technique; orientation of surgical specimen according to pre-established regional lymph node map -Mapping of regional lymph nodes by pathologist into perirectal zones (anterior, posterior, left, right, superior, middle, inferior)
- Compare pre- and post-therapeutic imaging with histopathological findings.
- Conditions
- Rectal Cancer
- Being tested
- ct and mri scans, ct, mri and pet scan, ct, mri and pet scans
- Keywords
- rectal cancer, imaging, PET, MRI
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ct and mri scansRadiation
ct and mri scan preradiation and postradiation
ct, mri and pet scanRadiation
ct, mri and pet scans preradiation and postradiation
ct, mri and pet scansRadiation
single arm with ct, mri and pet scans pre and post radiation
| Study group | Role | What they receive |
|---|---|---|
| imaging with ct, mri and pet scans | Other | ct,mri and pet scans pre and post radiation Receives: Radiation: ct and mri scans; Radiation: ct, mri and pet scan; Radiation: ct, mri and pet scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of PET, CT-perfusion and MRI to stage patients with rectal cancer
The patient will undergo imaging studies with PET, CT-perfusion and MRI before and after standard preoperative chemoradiation and these imaging studies will be compared with standard imaging and with the final pathology specimen in order to determine the accuracy of these 3 studies in detecting lymph node metastases and response of the primary tumour to treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Fisher, London Health Sciences Centre
- Investigators
- Barbara J Fisher, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525056
- Sponsor's protocol ID
- LRCP01
- Status last verified
- Sep 2014
- First submitted
- 25 Jan 2012
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Cancer: Local Staging, Re-staging and Assessment of Lymph Node Metastases Using PET-CT, CT-Perfusion and 3T MRI: A Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT01525056
- Acronym / sponsor ID
- LRCP01
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, imaging, PET, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the accuracy of Positron emission tomography, Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal cancer following neoadjuvant chemoradiation. The restaging result obtained by these imaging studies will be compared to standard imaging studies and the histopathology of the surgical specimen. We hypothesize that these 3 imaging modalities will detect lymph node metastases pretreatment better than standard pretreatment scans and will better determine the degree of response of the primary rectal tumor to preoperative chemoradiation.
Detailed description
Patient Recruitment:
30 consecutive patients with histologically-proven, non-mucinous rectal cancer will be recruited and stratified into three separate groups as follows:
- T2 tumors (requiring only surgery)
- Early T3 tumors (requiring preoperative standard course radiation therapy)
- Advanced T3 and T4 tumors (requiring preoperative chemoradiation)
Study Protocol:
The pretreatment imaging studies will be performed with a 3T MRI pelvis,PET-CT and CT-Perfusion of the pelvis. The patient will then receive standard treatment consisting of surgery,radiation therapy or a course of neoadjuvant chemoradiation.For patients with T3 and T4 tumors, repeat imaging using all three modalities outlined above will be performed post-treatment.
Histopathology \& data analysis
MRI Protocol:
All patients will be examined on a 3-T MRI unit (Siemens Medical, Germany) at St. Joseph's Hospital, London.
The MRI protocol is as follows:
- Buscopan 40 mg IM/IV prior to study
- Axial T2 TSE of the entire pelvis (aortic bifurcation to pubic symphysis)
- Sagittal T2 TSE (240 cm FOV) for detection of the rectal tumor
- Axial oblique T2 TSE (220 cm FOV) perpendicular to the rectal tumor
- 3 mm slice thickness
- Coronal T2 TSE (220 cm FOV)
- Axial DWI (B values 0, 500, 1000)
- ADC map
Unless otherwise specified, slice thickness is 4mm. Technique is free-breathing; no bowel preparation, intraluminal or intravascular contrast agents are administered.
PET-CT Protocol:
- Patient fasts for 6-12 hours prior to study, depending on timing of scan
- Patients to be scanned in the morning will fast overnight; those being scanned in the afternoon will fast for 6 hours following a light breakfast.
- Blood sugar level measurement prior to study (should be less than 11 mmol/L). Insulin dependent diabetics are scanned in the early afternoon following a light breakfast and routine morning insulin.
- Exclude pregnancy with urine/serum hCG
- Intravenous injection of 5MBq/kg of F-18 FDG)
- Intravenous injection of 20 mg Lasix, 10 minutes following F-18 FDG injection
- IV hydration with 250-500 mL of saline
- 60 minutes post-injection, acquire non contrast CT and positron emission tomography imaging of the pelvis
CT Perfusion Protocol:
All patients will undergo CT Perfusion with a 64-slice CT scanner (Discovery CT750 HD, GE Healthcare) at St. Joseph's Health Care, London.
The protocol is as follows:
- Preliminary non-contrast 2.5-mm-thick helical CT of the pelvic region (from the aortic bifurcation to the symphysis pubis) with free-breathing to locate a 8-cm section of the rectal tumor that was imaged in the MRI study.
- Prescribe a CT Perfusion study using the axial shuttle mode on the 8-cm section identified above. The perfusion study consists of two phases. The selected pelvic section is scanned every 2.8 s for 64.4 s (24 times) in the first phase and every 15 s for the next 120 s (8 times) in the second phase. The total duration of scanning is 184.4 s. The scanning parameters for both phases are: 120 kVp, 125 mA, 0.4 s rotation period, and 5 mm thick slices. All dynamic images will be reconstructed with adaptive statistical iterative reconstruction (ASIR) technique to reduce noise.
- Contrast injected at a rate of 3-4 ml/s will start at the same as the two-phase scanning, to allow for acquisition of 3-4 baseline volumes (before contrast arrives in the pelvis).
- Free-breathing is allowed during scanning.
- Contrast dose is 0.8ml/kg of body weight up to maximum of 70 ml of contrast at a concentration of 370 mg iodine/ml.
- The acquired dynamic contrast enhanced (DCE) images will be analyzed by CT Perfusion (GE Healthcare) to determine blood flow, blood volume, mean transit time and capillary permeability surface area of the tumor.
Surgical Resection and histopathological examination:
- Total mesorectal excision as per standardized surgical technique; orientation of surgical specimen according to pre-established regional lymph node map -Mapping of regional lymph nodes by pathologist into perirectal zones (anterior, posterior, left, right, superior, middle, inferior)
- Compare pre- and post-therapeutic imaging with histopathological findings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imaging with ct, mri and pet scans | Other | Radiation: ct and mri scans, Radiation: ct, mri and pet scan, Radiation: ct, mri and pet scansct,mri and pet scans pre and post radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rectal cancer, stage T2, T3, T4
Key exclusion criteria (9 listed)
- Rectal cancer, stage T1 or metastatic
- Non-rectal primary cancer invading the rectum
- Mucinous histology
- Patient is initially, or becomes a non-surgical candidate during the course of the study
- Hip prosthesis (affects PET-CT image processing)
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 |
|---|---|---|
| ct and mri scansct and mri scan preradiation and postradiation | Radiation | imaging with ct, mri and pet scans |
| ct, mri and pet scanct, mri and pet scans preradiation and postradiation | Radiation | imaging with ct, mri and pet scans |
| ct, mri and pet scanssingle arm with ct, mri and pet scans pre and post radiation | Radiation | imaging with ct, mri and pet scans |
Primary outcome
efficacy of PET, CT-perfusion and MRI to stage patients with rectal cancer
Time frame: 3 years
The patient will undergo imaging studies with PET, CT-perfusion and MRI before and after standard preoperative chemoradiation and these imaging studies will be compared with standard imaging and with the final pathology specimen in order to determine the accuracy of these 3 studies in detecting lymph node metastases and response of the primary tumour to treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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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.
Barbara J Fisher, MD principal investigator
Western University, Canada
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 ct and mri scans, ct, mri and pet scan and ct, mri and pet scans in people with Rectal Cancer, run by London Health Sciences Centre at 1 site in Canada.
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 1 inclusion and 9 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 9 Sep 2014. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
efficacy of PET, CT-perfusion and MRI to stage patients with rectal cancer (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2014.