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Locally Advanced Rectal CarcinomaEarly Phase 1NCT03280277

Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer

A Early Phase 1 study testing Contrast-enhanced Magnetic Resonance Imaging and Ferumoxytol in people with Locally Advanced Rectal Carcinoma and Stage III Rectal Cancer AJCC v7, run by OHSU Knight Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) works in imaging lymph nodes in patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Contrast-enhanced Magnetic Resonance Imaging and Ferumoxytol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
27 Apr 2018to 26 Aug 2021
Phase
Early Phase 1
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

  • Pathologically confirmed, locally advanced, malignancy of the rectum; based on multi-disciplinary tumor board discussion, patients are candidates for tri-modality treatment
  • Stage T1-4bN1-2, by the American Joint Committee on Cancer (AJCC) 7th edition, based on the following minimum workup:
  • CT chest/abdomen with contrast
  • MRI pelvis with contrast
  • PET/CT of the whole-body or skull base to mid-thigh
  • Subjects must have had no prior therapy for cancer of the rectum
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  • Members of all races and ethnic groups will be included
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • White blood cell count >= 3.0 K/cu mm
  • Absolute neutrophil count >= 1.5 K/cu mm
  • Platelets >= 100 K/cu mm
  • Hemoglobin >= 8.0 g/dl (the use of transfusion or other invention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Total bilirubin =< 1.5 X institutional upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for subjects with creatinine levels above institutional normal
  • Woman of childbearing potential, a negative serum or urine pregnancy test
  • Willingness to use adequate contraception for 12 months after completion of all therapy
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Subjects with AJCC 7th edition stage TxN0 and/or metastatic disease outside of pelvis (suspicious lateral pelvic lymph nodes up to and including common iliacs are allowed on the protocol)
  • Prior systemic chemotherapy for rectal cancer; prior chemotherapy for another malignancy is allowable as long as it has been > 2 years since completion of therapy for previous malignancy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol or other agents used in the study
  • Prior abdominopelvic radiation or radiation for rectal cancer
  • History of other malignancy in the past 2 years except non-melanomatous skin cancer, breast ductal carcinoma in situ (DCIS) and low-risk prostate adenocarcinoma
  • Medical contraindications to low anterior resection or abdominoperineal resection
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  • Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because chemoradiotherapy has the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to the use of ferumoxytol as a contrast agent in the mother, breastfeeding should be discontinued if the mother receives ferumoxytol while nursing; men who are sexually active and not willing/able to use medically acceptable forms of contraception are also excluded from this study
  • Subjects with multiple drug allergies and/or subjects who have had an allergic reaction to any intravenous iron replacement product or a known history of hypersensitivity to ferumoxytol
  • Subjects with concurrent clinical diagnosis of evidence of active iron overload defined by the following 1) ferritin >= 250 ng/mL in men or >= 200 ng/mL in women AND 2) transferrin saturation, the ratio of plasma iron to transferrin, expressed as percent, >= 45%
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
  • Patients with renal insufficiency; glomerular filtration rate (GFR) < 60
  • Adult patients who require monitored anesthesia for MRI scanning
  • Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
  • Subjects with known hepatic insufficiency or cirrhosis as determined by either a prior diagnosing physician or at review at initial consultation; these disease entities do not have formal associated lab values and are thus a clinical diagnosis by the prior aforementioned physician

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Novel Imaging of Lymph Nodes in Patients With Rectal Cancer Using Ferumoxytol Enhanced MRI

This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) works in imaging lymph nodes in patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Ferumoxytol is a form of very small iron particles that are taken up by cells in normal lymph nodes and may work better in imaging patients with rectal cancer when given with MRI.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine feasibility of administering ferumoxytol and obtaining ferumoxytol enhanced magnetic resonance (MR) images in patients with resectable locally advanced rectal cancer with enlarged or suspicious lateral pelvic lymph nodes before starting neoadjuvant therapy and again before total mesorectal excision.

SECONDARY OBJECTIVES:

  1. To collect detailed information about the location of ultrasmall superparamagnetic iron oxide (USPIO)-MRI detected lymph nodes prior to neoadjuvant therapy and again prior to total mesorectal excision.

II. To compare the sensitivity and specificity of ferumoxytol enhanced MR imaging in assessment of pathological lymph nodes with those of non-USPIO-MRI and positron emission tomography-computed tomography (PET-CT).

OUTLINE:

Patients receive ferumoxytol intravenously (IV) over 15 minutes and then after 24-36 hours undergo ferumoxytol-enhanced MRI before start of neoadjuvant therapy and within 4 weeks before surgery.

After completion of study treatment, patients are followed up for 4-6 weeks.

Being tested
Contrast-enhanced Magnetic Resonance Imaging, Ferumoxytol
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast-enhanced Magnetic Resonance ImagingProcedure or surgery

    Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI

    Undergo ferumoxytol-enhanced MRI

  • FerumoxytolDrug

    Also called Feraheme, Ferumoxytol Non-Stoichiometric Magnetite

    Given IV

Study groups in NCT03280277
Study groupRoleWhat they receive
Diagnostic (ferumoxytol-enhanced MRI)ExperimentalPatients receive ferumoxytol IV over 15 minutes and then after 24-36 hours undergo ferumoxytol-enhanced MRI before start of neoadjuvant therapy and within 4 weeks before surgery.
Receives: Procedure: Contrast-enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Practical feasibility

    Assessed by successful accrual objectively, as a percentage of all subjects enrolled. Accrual success will be measured in binary fashion; successful accrual is considered a patient that enrolls and completes the entire trial. All other eligible patients will be considered an accrual failure. Practical feasibility will be considered a success if greater than 50%.

    Measured: Up to 6 weeks

  2. Technical feasibility of ultrasmall superparamagnetic iron oxide (USPIO) - magnetic resonance imaging (MRI) of the chest

    Assessed by image quality and protocol completion. Will be evaluated in a descriptive manner. Image quality, readability (i.e. the ability for diagnostic radiologist to make an appropriate diagnostic conclusion), completion of ferumoxytol infusion, data acquisition, and completion of magnetic resonance protocol.

    Measured: Up to 6 weeks

Secondary outcomes (5)

  1. Reason for accrual failure

    Measured: Up to 6 weeks

  2. Report location and enhancement patterns on USPIO - MRI

    Measured: Up to 6 weeks

  3. Sensitivity and specificity of MRI imaging for all lymph nodes

    Assessed by pathology finding. Sensitivities and specificities of ferumoxytol enhanced MRI prior to neoadjuvant therapy will be calculated using pathology finding as the gold standard. Each lymph node will be treated as an independent observation. The sensitivity and specificity will be compared with those from positron emission tomography (PET)/computed tomography (CT) findings using McNemar's test. Sensitivities and specificities of ferumoxytol enhanced MRI before surgery will also be calculated as a reference.

    Measured: Up to 6 weeks

  4. Sensitivity and specificity of PET/CT imaging

    Assessed by pathology finding. Sensitivities and specificities of ferumoxytol enhanced MRI prior to neoadjuvant therapy will be calculated using pathology finding as the gold standard. Each lymph node will be treated as an independent observation. The sensitivity and specificity will be compared with those from PET/CT findings using McNemar's test. Sensitivities and specificities of ferumoxytol enhanced MRI before surgery will also be calculated as a reference.

    Measured: Up to 6 weeks

  5. Accuracy of USPIO - MRI

    Accuracy, which is defined as the percentage of all patients or lymph nodes in which MRI with ferumoxytol correctly predicted the presence or absence of metastatic tumor, will be calculated.

    Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study start27 Apr 2018
  3. Primary completion26 Aug 2021
  4. Study completion26 Aug 2021

Why it stopped: low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03280277
Sponsor's protocol ID
STUDY00016101
Other IDs
NCI-2017-00388, ONC-16108-L, STUDY00016101
Status last verified
Sep 2021
First submitted
23 May 2017
Last updated
10 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Contrast-enhanced Magnetic Resonance Imaging and Ferumoxytol in people with Locally Advanced Rectal Carcinoma and Stage III Rectal Cancer AJCC v7, run by OHSU Knight Cancer Institute 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 18 inclusion and 15 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: stopped early, as of the sponsor's last update on 10 Sep 2021. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 was stopped early (reason given: low accrual). Results are not available in the source record.

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?

Practical feasibility (time frame: Up to 6 weeks). 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?

On the ClinicalTrials.gov record for NCT03280277.

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 10 Sep 2021.

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