Uterine NeoplasmsPhase 1/2NCT00188695
Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide
A Phase 1/2 study testing MRI contrast agent Combidex (ferumoxtran-10) in people with Uterine Neoplasms and Cervix Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to test whether or not a new contrast agent called Combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uterine Neoplasms, Cervix Neoplasms, Bladder Neoplasms
- What is being tested?
- MRI contrast agent Combidex (ferumoxtran-10)
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2004to 15 Mar 2022
- Phase
- Phase 1/2
- 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
- histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer
- no distant metastases
- informed consent
Who cannot join
- confirmed prostate carcinoma and PSA less than or equal to 4 or greater than 100
- radical surgery or prior cryosurgery for prostate carcinoma, previous RT, hormonal manipulation or chemotherapy
- biopsy-proven lymph node involvement
- endometrium or cervix carcinoma who have undergone recent pelvic surgery with the exclusion of D\&C or biopsy
- bladder carcinoma with recent pelvic surgery with the exclusion of TURBT
- previous or concurrent cancers other than superficial basal or squamous cell skin carcinoma unless disease-free for at least 5 yrs
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- contraindication to MR imaging
- hip prosthesis
- major medical or psychiatric illness
- patients with known allergy to dextran or iron-containing compounds
- patients with cirrhosis or hemochromatosis
- patients receiving another MR contrast within 2 hrs prior to the ferumoxtran-10
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition
The purpose of this study is to test whether or not a new contrast agent called Combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also help doctors tell whether or not cancer has spread to these lymph nodes. It might allow radiotherapy to be delivered more accurately.
- Being tested
- MRI contrast agent Combidex (ferumoxtran-10)
- Medical subject headings
- Uterine Neoplasms, Uterine Cervical Neoplasms, Urinary Bladder Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI contrast agent Combidex (ferumoxtran-10)Procedure or surgery
Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.
Measured: once at time of imaging
Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).
Measured: once at time of imaging
Secondary outcomes (2)
Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.
Measured: once at time of imaging
Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.
Measured: once at time of imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionJun 2006
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Investigators
- Michael Milosevic, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188695
- Sponsor's protocol ID
- 03-0838-C
- Status last verified
- Oct 2022
- First submitted
- 12 Sep 2005
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition
- ClinicalTrials.gov ID
- NCT00188695
- Acronym / sponsor ID
- 03-0838-C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Apr 2004 (actual)
- Primary completion
- Jun 2006 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 16 Sep 2005 (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 test whether or not a new contrast agent called Combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also help doctors tell whether or not cancer has spread to these lymph nodes. It might allow radiotherapy to be delivered more accurately.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer
- no distant metastases
- informed consent
Key exclusion criteria (12 listed)
- confirmed prostate carcinoma and PSA less than or equal to 4 or greater than 100
- radical surgery or prior cryosurgery for prostate carcinoma, previous RT, hormonal manipulation or chemotherapy
- biopsy-proven lymph node involvement
- endometrium or cervix carcinoma who have undergone recent pelvic surgery with the exclusion of D\&C or biopsy
- bladder carcinoma with recent pelvic surgery with the exclusion of TURBT
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 |
|---|---|---|
| MRI contrast agent Combidex (ferumoxtran-10)Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases. | Procedure or surgery | – |
Primary outcome
Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.
Time frame: once at time of imaging
Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).
Time frame: once at time of imaging
2 secondary outcomes
Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.
Time frame: once at time of imaging
Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.
Time frame: once at time of imaging
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 7 Oct 2022.
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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.
Michael Milosevic, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MRI contrast agent Combidex (ferumoxtran-10) in people with Uterine Neoplasms and Cervix Neoplasms, run by University Health Network, Toronto 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 3 inclusion and 12 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 7 Oct 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers. (time frame: once at time of imaging). The study lists 2 primary outcomes in all. 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 7 Oct 2022.