Rectal NeoplasmsNCT02537340
PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
An observational study of Rectal Neoplasms, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
The hypothesis to be proven with this study is that the use of PET/MR on the initial staging of rectal cancers in patients with extramural vascular invasion detected by MR will detect more lesions than conventional work-up and will significantly impact on therapeutic decision, improving disease free and overall… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2016to May 2019
- Phase
- Observational
- 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
Study population: Patients with histologically proven rectal cancer.
Who may be able to join
- Age > 18 years;
- No contraindication to MRI (eletromagnetic devices, claustrophobia);
- No contraindication to PET/MR (hyperglycemia, claustrophobia);
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Local resection of rectal tumor;
- Non-colorectal synchronic lesion;
- Previous treatment (chemo or radiation therapy) for rectal cancer;
- Renal insufficiency;
- Pregnancy, lactation or inadequate contraception
- Known allergy to contrast media (CT, MR or PET);
- Blood glucose level higher than 150 mg/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of PET/MR for Initial Staging of Rectal Cancer Patients With Extramural Vascular Invasion Detected by MR (EMVI-MR)
The hypothesis to be proven with this study is that the use of PET/MR on the initial staging of rectal cancers in patients with extramural vascular invasion detected by MR will detect more lesions than conventional work-up and will significantly impact on therapeutic decision, improving disease free and overall survival.
Read the detailed description
The accurate staging of rectal cancer is essential to define therapy and for prognosis assessment. Imaging modalities usually provide useful information for pre-operative planning of primary tumour resection and may indicate the need of neoadjuvant treatment. It is recommended the use of magnetic resonance imaging (MRI) for local staging and computed tomography (CT) of chest, abdomen and pelvis for detection of distant metastasis. Patients with rectal cancer and vascular invasion might benefit from an intensive pre-operative staging in order to early detect distant metastasis, favouring a better therapeutic planning. There is no consensus regarding the use of PET/MR for initial staging of patients with rectal cancer. It has been shown that although changing pattern's in patients' stage, the use of PET/MR for colorectal cancers did not impact disease management. New studies are required for identifying the subgroup of patients with changes in the pre-operative MR that might benefit from the use of PET/MR for initial staging of rectal cancers.
Patients with rectal cancer will undergo pelvic MR, whole-body CT and whole-body PET/MR. According to the tumour characteristics on MR, there will be defined two group of patients: with EMVI-RM (group A) and without EMVI-MR (group B). The whole-body CT and PET/MR will be evaluated for the detection of loco-regional lymph nodes disease and distant metastasis. The total number of lesions and their respective sites will be recorded and compared for each method. The PET/MR management impact will be determined from the medical record or by direct contact with the treating clinician. The impact of PET/MR on management will be defined as high (the treatment modality or intent was changed), medium (the treatment modality or intent remained unchanged, although the method of treatment delivery or planned diagnostic procedure was changed), low (PET/MR results were consistent with planned management, and treatment modality or intent was unchanged), or none (the management plan was not changed, despite being inconsistent with the PET/MR stage-that is, PET/MR results were ignored). Overall survival will be used to evaluate prognostic significance. Clinical follow-up will be performed 3 monthly for 2 years. Imaging and, eventually biopsy, will be performed to evaluate symptoms or signs suggestive of residual or recurrent disease.
- Conditions
- Rectal Neoplasms
- Keywords
- PET/MR, MRI, Rectal cancer, EMVI, FDG
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EMVI-MR positive | Patients with primary rectal cancer and extramural vascular invasion detected by staging MR | |
| EMVI-MR negative | Patients with primary rectal cancer and without extramural vascular invasion detected by staging MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate
Number of metastatic lesions detected
Measured: 12 months
Secondary outcomes (3)
Clinical Impact
Measured by change in patient's therapy through questionnaire applied to referring physician
Measured: 12 months
Progression-free survival
Measured in terms of loco-regional or distant recurrence by 3 years.
Measured: 36 months
Overall survival
Measured in terms of death related to disease by 3 years.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2016
- Primary completionApr 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Marcelo Araujo Queiroz, Instituto do Cancer do Estado de São Paulo
- Investigators
- Carlos Buchpiguel, MD, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537340
- Sponsor's protocol ID
- NP796/15
- Status last verified
- Jun 2020
- First submitted
- 30 Aug 2015
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Queiroz MA, Ortega CD, Ferreira FR, Capareli FC, Nahas SC, Cerri GG, Buchpiguel CA. Value of Primary Rectal Tumor PET/MRI in the Prediction of Synchronic Metastatic Disease. Mol Imaging Biol. 2022 Jun;24(3):453-463. doi: 10.1007/s11307-021-01674-1. Epub 2021 Nov 9.
PubMed 34755248Queiroz MA, Ortega CD, Ferreira FR, Nahas SC, Cerri GG, Buchpiguel CA. Diagnostic accuracy of FDG-PET/MRI versus pelvic MRI and thoracic and abdominal CT for detecting synchronous distant metastases in rectal cancer patients. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):186-195. doi: 10.1007/s00259-020-04911-x. Epub 2020 Jun 20.
PubMed 32561971
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of PET/MR for Initial Staging of Rectal Cancer Patients With Extramural Vascular Invasion Detected by MR (EMVI-MR)
- ClinicalTrials.gov ID
- NCT02537340
- Acronym / sponsor ID
- NP796/15
- Conditions
- Rectal Neoplasms
- Keywords
- PET/MR, MRI, Rectal cancer, EMVI, FDG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 1 Sep 2015 (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 hypothesis to be proven with this study is that the use of PET/MR on the initial staging of rectal cancers in patients with extramural vascular invasion detected by MR will detect more lesions than conventional work-up and will significantly impact on therapeutic decision, improving disease free and overall survival.
Detailed description
The accurate staging of rectal cancer is essential to define therapy and for prognosis assessment. Imaging modalities usually provide useful information for pre-operative planning of primary tumour resection and may indicate the need of neoadjuvant treatment. It is recommended the use of magnetic resonance imaging (MRI) for local staging and computed tomography (CT) of chest, abdomen and pelvis for detection of distant metastasis. Patients with rectal cancer and vascular invasion might benefit from an intensive pre-operative staging in order to early detect distant metastasis, favouring a better therapeutic planning. There is no consensus regarding the use of PET/MR for initial staging of patients with rectal cancer. It has been shown that although changing pattern's in patients' stage, the use of PET/MR for colorectal cancers did not impact disease management. New studies are required for identifying the subgroup of patients with changes in the pre-operative MR that might benefit from the use of PET/MR for initial staging of rectal cancers.
Patients with rectal cancer will undergo pelvic MR, whole-body CT and whole-body PET/MR. According to the tumour characteristics on MR, there will be defined two group of patients: with EMVI-RM (group A) and without EMVI-MR (group B). The whole-body CT and PET/MR will be evaluated for the detection of loco-regional lymph nodes disease and distant metastasis. The total number of lesions and their respective sites will be recorded and compared for each method. The PET/MR management impact will be determined from the medical record or by direct contact with the treating clinician. The impact of PET/MR on management will be defined as high (the treatment modality or intent was changed), medium (the treatment modality or intent remained unchanged, although the method of treatment delivery or planned diagnostic procedure was changed), low (PET/MR results were consistent with planned management, and treatment modality or intent was unchanged), or none (the management plan was not changed, despite being inconsistent with the PET/MR stage-that is, PET/MR results were ignored). Overall survival will be used to evaluate prognostic significance. Clinical follow-up will be performed 3 monthly for 2 years. Imaging and, eventually biopsy, will be performed to evaluate symptoms or signs suggestive of residual or recurrent disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMVI-MR positive | – | –Patients with primary rectal cancer and extramural vascular invasion detected by staging MR |
| EMVI-MR negative | – | –Patients with primary rectal cancer and without extramural vascular invasion detected by staging MR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically proven rectal cancer.
Key inclusion criteria (4 listed)
- Age > 18 years;
- No contraindication to MRI (eletromagnetic devices, claustrophobia);
- No contraindication to PET/MR (hyperglycemia, claustrophobia);
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (7 listed)
- Local resection of rectal tumor;
- Non-colorectal synchronic lesion;
- Previous treatment (chemo or radiation therapy) for rectal cancer;
- Renal insufficiency;
- Pregnancy, lactation or inadequate contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection rate
Time frame: 12 months
Number of metastatic lesions detected
3 secondary outcomes
Clinical Impact
Time frame: 12 months
Progression-free survival
Time frame: 36 months
Overall survival
Time frame: 36 months
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 22 Jun 2020.
- Derived from this study: PubMed 34755248Queiroz MA, Ortega CD, Ferreira FR, Capareli FC, Nahas SC, Cerri GG, Buchpiguel CA. Value of Primary Rectal Tumor PET/MRI in the Prediction of Synchronic Metastatic Disease. Mol Imaging Biol. 2022 Jun;24(3):453-463. doi: 10.1007/s11307-021-01674-1. Epub 2021 Nov 9.
- Derived from this study: PubMed 32561971Queiroz MA, Ortega CD, Ferreira FR, Nahas SC, Cerri GG, Buchpiguel CA. Diagnostic accuracy of FDG-PET/MRI versus pelvic MRI and thoracic and abdominal CT for detecting synchronous distant metastases in rectal cancer patients. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):186-195. doi: 10.1007/s00259-020-04911-x. Epub 2020 Jun 20.
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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.
Carlos Buchpiguel, MD, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 4 inclusion and 7 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 22 Jun 2020. 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 Brazil. 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.
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?
Detection rate (time frame: 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 NCT02537340, which also lists 2 linked publications.
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 22 Jun 2020.