Rectal NeoplasmsPhase 3NCT02751606
Nano MRI on 7 Tesla in Rectal and Breast Cancer
A Phase 3 study testing ferumoxtran-10, 7 Tesla MRI and 3 Tesla MRI in people with Rectal Neoplasms and Breast Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms, Breast Neoplasms
- What is being tested?
- ferumoxtran-10, 7 Tesla MRI and 3 Tesla MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Nov 2019
- Phase
- Phase 3
- 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
- General criteria:
- Age > 18 years
- Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.
- Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy or will undergo an axillary lymph node dissection without prior sentinel node procedure and will receive no neo-adjuvant therapy.
Who cannot join
- General exclusion criteria:
- BMI > 30 kg/m2
- Pregnancy
- Karnofsky score <= 70
- Contraindications for 7T MRI:
- Epilepsy
Show all 16Show fewer
- Inability to provide informed consent
- Metal implants that are not compatible with 7 Tesla MRI
- Contraindications to USPIO based contrast agents:
- prior allergic reaction to ferumoxtran-10 or any other iron preparation
- prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
- prior allergic reaction to contrast media of any type
- hereditary hemochromatosis, thalassemia, sickle cell anemia;
- Inflammatory diseases of the abdomen (such as Crohn's disease)
- Previous abdominal surgery or radiotherapy
- Prior radiotherapy or surgery to axillae
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Centre
Nijmegen, Gelderland, 6500HB
Bart Philips, MD, 0631961348, bartphilips1@gmail.com
Tom Scheenen, PhD
About this study
Official title: Nano MRI on 7 Tesla: a Technical Validation Study in Rectal and Breast Cancer
This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.
Read the detailed description
The Presence of lymph node metastases in cancer is a key factor for determining prognosis and forming an adequate treatment plan. Determining lymph node status, however, is a challenge. Ferumoxtran-10, an ultrasmall superparamagnetic iron oxide (USPIO) particle has proven to be a valuable contrast agent for detecting lymph node metastases using magnetic resonance imaging (MRI) in various types of cancer (also called nano-MRI). For small lymph node metastases (<5mm) the diagnostic accuracy of this technique does, however, drop substantially. Most of the studies that have been performed with these particles used a 1.5 Tesla or 3 Tesla MRI scanner. The investigators would like to increase the resolution of nano-MRI by using a 7 Tesla scanner, such that the investigators can increase the sensitivity of this technique for small lymph nodes. With this study the investigators would like to validate the results of this technique with pathology in rectal and breast cancer. In these cancer types many patients undergo a surgical lymph node dissection by bulk excision of tissue including the nodes, enabling a node-to-node comparison between MRI and pathology to validate our nano-MRI results . If successful this technique would form a non-invasive alternative to the current lymph node staging techniques such as surgery. Additionally (if metastatic nodes are present), it could complement image guided focal therapies on lymph node metastases such as radiotherapy.
- Conditions
- Rectal Neoplasms, Breast Neoplasms
- Being tested
- ferumoxtran-10, 7 Tesla MRI, 3 Tesla MRI
- Keywords
- Ferumoxtran, MRI Scans
- Medical subject headings
- Rectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferumoxtran-10Drug
ferumoxtran-10 will be administered intravenously one day prior to the MRI scan
7 Tesla MRIDevice
Subjects undergo a 7 Tesla MRI scan
3 Tesla MRIDevice
Subjects undergo a 3 Tesla MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Breast and rectal cancer | Experimental | Subjects will receive intravenous dose of ferumoxtran-10. 24-36 hours later a 7 Tesla MRI scan will be performed, to detect lymph node metastases. In rectal cancer patients the mesorectum will be imaged and for breast cancer patients this will be performed in the ipsilateral axilla. Subjects will also undergo a 3 Tesla MRI scan as a comparison to the 7 Tesla MRI scan. Receives: Drug: ferumoxtran-10; Device: 7 Tesla MRI; Device: 3 Tesla MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of 7 Tesla MRI in combination with ferumoxtran-10 on nodal level.
The images of the 7 Tesla MRI scan will be evaluated by a radiologist and every lymph node that is found will be scored as positive or negative. This will be compared to the pathological results to determine the sensitivity and specificity of ferumoxtran enhanced MRI on 7 Tesla for diagnosing whether a lymph node is metastatic or not.
Measured: within 2 weeks prior to the patients surgery
Secondary outcomes (1)
Comparison of 7 Tesla and 3 Tesla MRI
The diagnostic accuracy (sensitivity and specificity as described in outcome 1) of 3 Tesla and 7 Tesla will be compared
Measured: within 2 weeks prior to the patients surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Scheenen, PhD, Principal investigator, Radboudumc Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751606
- Sponsor's protocol ID
- 7TNANO1
- Status last verified
- Sep 2017
- First submitted
- 28 Nov 2014
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano MRI on 7 Tesla: a Technical Validation Study in Rectal and Breast Cancer
- ClinicalTrials.gov ID
- NCT02751606
- Acronym / sponsor ID
- 7TNANO1
- Conditions
- Rectal Neoplasms, Breast Neoplasms
- Keywords
- Ferumoxtran, MRI Scans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 26 Apr 2016 (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.
This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.
Detailed description
The Presence of lymph node metastases in cancer is a key factor for determining prognosis and forming an adequate treatment plan. Determining lymph node status, however, is a challenge. Ferumoxtran-10, an ultrasmall superparamagnetic iron oxide (USPIO) particle has proven to be a valuable contrast agent for detecting lymph node metastases using magnetic resonance imaging (MRI) in various types of cancer (also called nano-MRI). For small lymph node metastases (<5mm) the diagnostic accuracy of this technique does, however, drop substantially. Most of the studies that have been performed with these particles used a 1.5 Tesla or 3 Tesla MRI scanner. The investigators would like to increase the resolution of nano-MRI by using a 7 Tesla scanner, such that the investigators can increase the sensitivity of this technique for small lymph nodes. With this study the investigators would like to validate the results of this technique with pathology in rectal and breast cancer. In these cancer types many patients undergo a surgical lymph node dissection by bulk excision of tissue including the nodes, enabling a node-to-node comparison between MRI and pathology to validate our nano-MRI results . If successful this technique would form a non-invasive alternative to the current lymph node staging techniques such as surgery. Additionally (if metastatic nodes are present), it could complement image guided focal therapies on lymph node metastases such as radiotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast and rectal cancer | Experimental | Drug: ferumoxtran-10, Device: 7 Tesla MRI, Device: 3 Tesla MRISubjects will receive intravenous dose of ferumoxtran-10. 24-36 hours later a 7 Tesla MRI scan will be performed, to detect lymph node metastases. In rectal cancer patients the mesorectum will be imaged and for breast cancer patients this will be performed in the ipsilateral axilla. Subjects will also undergo a 3 Tesla MRI scan as a comparison to the 7 Tesla MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.
- Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy or will undergo an axillary lymph node dissection without prior sentinel node procedure and will receive no neo-adjuvant therapy.
Key exclusion criteria (16 listed)
- BMI > 30 kg/m2
- Pregnancy
- Karnofsky score <= 70
- Contraindications for 7T MRI:
- Contraindications to USPIO based contrast agents:
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 |
|---|---|---|
| ferumoxtran-10ferumoxtran-10 will be administered intravenously one day prior to the MRI scan | Drug | Breast and rectal cancer |
| 7 Tesla MRISubjects undergo a 7 Tesla MRI scan | Device | Breast and rectal cancer |
| 3 Tesla MRISubjects undergo a 3 Tesla MRI scan | Device | Breast and rectal cancer |
Primary outcome
Sensitivity and specificity of 7 Tesla MRI in combination with ferumoxtran-10 on nodal level.
Time frame: within 2 weeks prior to the patients surgery
The images of the 7 Tesla MRI scan will be evaluated by a radiologist and every lymph node that is found will be scored as positive or negative. This will be compared to the pathological results to determine the sensitivity and specificity of ferumoxtran enhanced MRI on 7 Tesla for diagnosing whether a lymph node is metastatic or not.
1 secondary outcome
Comparison of 7 Tesla and 3 Tesla MRI
Time frame: within 2 weeks prior to the patients surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
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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.
Tom Scheenen, PhD principal investigator
Radboudumc Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ferumoxtran-10, 7 Tesla MRI and 3 Tesla MRI in people with Rectal Neoplasms and Breast Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
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 16 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: status not confirmed, as of the sponsor's last update on 6 Dec 2018. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bart Philips, MD (+31 24 36 68392, Bart.Philips@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of 7 Tesla MRI in combination with ferumoxtran-10 on nodal level. (time frame: within 2 weeks prior to the patients surgery). 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 6 Dec 2018.