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Malignant Tumor of BreastNCT05305937

Implantation of CEST and CESL MRI Methods for Detection of Breast Tumors

A study testing MRI scan in people with Malignant Tumor of Breast and Benign Breast Lumps, run by Meir Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

MRI is a well-established method in breast imaging. It gives excellent morphological information but does not reflect the metabolic activity leading to high proportion of false positive results. PET-CT fulfills this gap but suffers from low resolution and the risk of radiation damage. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
MRI scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
May 2022to 31 May 2025
Phase
Interventional
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women with suspicious finding/process in the breast that requires MRI examination
  • Age: Over 18 years.
  • For 10 patients of control group - patients without breast tumor, carriers of mutations in P53, BRCA2, BRCA1 or PTEN genes or women after genetic counseling who have been defined as having a 20% risk of developing breast cancer and are undergoing routine MRI.

Who cannot join

  • Pregnancy or breastfeeding
  • Sensitivity to glucosamine and / or gadolinium.
  • Renal failure with creatinine clearance less than 30 cc per minute.
  • Weight over 130 kg.
  • Patients who have undergone breast surgery in the past year.
  • Claustrophobia.
Show all 17Show fewer
  • Cardiovascular instability, symptomatic heart disease, pacemaker, artificial heart valve.
  • Intra-body injection device.
  • A generalized (idiopathic) epileptic seizure that is pharmacologically unbalanced.
  • Metabolic instability (water economy, electrolytes, sugar).
  • Suffers from a gastrointestinal disorder that affects absorption.
  • Fever or evidence of a microbiological contaminant.
  • Women using drugs that are related to derivatives of warfarin-coumadin.
  • Women with phenylketonuria
  • Inability to sign informed consent.
  • COVID-19
  • In addition, all examinees will be subject to the accepted criteria for inclusion and exclusion of the MRI unit at Meir Medical Center.

About this study

MRI is a well-established method in breast imaging. It gives excellent morphological information but does not reflect the metabolic activity leading to high proportion of false positive results. PET-CT fulfills this gap but suffers from low resolution and the risk of radiation damage. Lately, chemical exchange saturation transfer (CEST) MRI of glucose has been proposed as a new molecular imaging approach for diagnosing tumors given its high sensitivity at the molecular level and the known enhanced glucose uptake by tumors. Several glucose analogs were examined as possible candidates for imaging of breast tumors. One of the most promising agent for CEST-MRI is glucosamine (GlcN); owing to its phosphorylated products that accumulate in breast tumors, it enables to reflect their metabolic profile. In preclinical experiments glucosamine exhibits enhanced CEST signals in 4T1 and MCF7 implanted breast cancer cells in mice. Its potential for the human clinical application is strengthened by its lack of toxicity. Here the investigators propose to test the method for human subjects on a clinical MRI setup. The goal of this study is to develop innovative molecular imaging modality based on CEST-MRI of GlcN for the detection of breast tumors. The investigators will use the newly developed CEST-MRI modality for the detection of benign and malignant breast cancer in a clinical MRI scanner.

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Read the detailed description

The primary aim of this study is to develop innovative molecular imaging modality based on the chemical exchange saturation transfer MRI (CEST-MRI) of glucosamine (GlcN) to visualize and measure breast tumors. GlcN has been shown to have good breast tumor targeting properties allowing its detection in laboratory animals under CEST MRI technique. The investigators will use the newly developed CEST-MRI modality for the detection of benign and malignant breast cancer in a clinical MRI scanner

STUDY AIMS

  1. Investigate the possibility of obtaining a new contrast image of breast cancer tumors using glucosamine as a new contrast agent using the CEST imaging method (Chemical Exchange Saturation Transfer chemical exchange during saturation transition) and/or the CESL (Spin Lock chemical exchange method).
  2. A comparison of the contrast image obtained by the novel GlcN CEST-MRI and/or CESL-MRI methods to that obtained by traditional MRI methods like T1, T2.
  3. Using the GlcN- CEST-MRI / or CESL-MRI approaches, compare the signal obtained by malignant and benign tumors, examination if these methods can distinguish between the two types of tumors.

Patients bearing solid breast tumors will be scanned at the clinical MRI setup. The scans will include short anatomical scans (of T1 and T2 images) and CEST imaging. Patients will be required to fast for at least 4 hours before the scan (can drink water during fasting). The participants will be asked to drink glucosamine solution (184 mg/kg). Patients will be scanned twice during the same MRI session, before and 2 hours after taking glucosamine orally. In addition to the CEST scans with GlcN, patients will undergo MRI scans with the standard contrast agent of gadolinium. This procedure will be done following the CEST scan. The CEST scan takes a few minutes (up to 10 minutes).

Being tested
MRI scan
Medical subject headings
Breast Neoplasms

What participants receive

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

  • MRI scanDevice

    All patients will be scanned twice during the same MRI session, before and 2 hours after taking glucosamine orally. In addition to the CEST scans with glucosamine, patients will undergo MRI scans with the standard contrast agent of gadolinium. This procedure will be done following the CEST scan

Study groups in NCT05305937
Study groupRoleWhat they receive
One arm - all patientsExperimentalNot described
Receives: Device: MRI scan

What is being measured

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

  1. Detection and diagnosis of malignant tumors in the breast

    Detection and diagnosis of malignant tumors in the breast without the use of gadolinium contrast agent.

    The proposed GlcN CEST MRI method is based on the ability of tumors to accumulate glucosamine in a preferred manner (Warburg effect). Therefore, the new method allows the acquisition of new information that is not obtained by other imaging methods: the method allows the presentation of a new contrast image in MRI that expresses metabolic changes in the tumor, expressed as % GlcN CEST.

    Measured: up to three years (MRI scans and data collection and interpretation will last up to 2 years; post processing, reports and publications will last about one more year)

Secondary outcomes (4)

  1. Tumor classification: benign or malignant

    It is hypothesized that the proposed study will allow to distinguish between malignant and benign tumors based on the quantification of glucosamine and its metabolites uptake in the tumor. Tools for assessing this outcome measure:

    Construction of a CEST scale bar based on magnetization transfer asymmetry ratio (MTRasym) maps that will be evaluated on a predetermined scale (expressing the effect as %).

    A GlcN signal rising over or equivalent to the MTRasym impact of 3% will be considered as a success metric for malignant tumors. MTRasym percentages are expected to be minimal to zero in benign tumors because GlcN uptake is likely to be poor.

    Measured: 3 years (data collection and post processing)

  2. Glucosamine CEST scale bar

    Create a scale bar representing the CEST intensity (percent) in the tumor, which will be used to determine the degree of malignancy.

    Measured: Three years (data collection and post processing)

  3. Finding correlation between research results and selected pathological parameters to better identify breast cancer

    In order to examine and/or assess the correlation between disease manifestation and the GlcN CEST MRI finding, the research results will be compared to selected pathological/ histopathological parameters of the patients (such as disease classification, grade, presence of estrogen receptors, progesterone receptor status, HER2, Ki-67 status, and so on). The statistical significance of the correlation will be assessed

    Measured: 3 years (data collection and statistical evaluation)

  4. Using Mathematical model

    As glucosamine accumulates in tumors, the level of malignancy and activity of distinct regions in the tumor can be assessed using mathematical modeling of the numerous products that contribute to the CEST MRI signal.

    To resolve individual contributions to the GlcN CEST effect, the Z spectra will be analyzed using a multi-pool Gaussian fitting model for the separation of the water, Magnetization transfer (MT), hydroxyl, amine/amide, and Nuclear Overhauser enhancement (NOE) signals.

    The fitting of the Z-spectrum to the sum of multiple Gaussian functions will be performed using the following equation: y= iAiexp [ -4ln2(x-ωi)2 / σi2] where ω is the frequency offset from the water resonance (ppm), and Ai, ωi and σi are the amplitude, frequency offset (ppm) and linewidth (ppm) of the CEST peak for the ith proton pool, respectively. Thus, using the multi-pool Gaussian fitting approach will enable to account for the contribution of each metabolite to the total GlcN CEST effect.

    Measured: up to 3 years (post processing-1 year)

Timeline

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

  1. First posted31 Mar 2022
  2. Study startMay 2022 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 May 2025 (estimated)

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
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05305937
Sponsor's protocol ID
0201-21
Status last verified
Mar 2022
First submitted
23 Feb 2022
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MRI scan in people with Malignant Tumor of Breast and Benign Breast Lumps, run by Meir Medical Center.

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 17 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Detection and diagnosis of malignant tumors in the breast (time frame: up to three years (MRI scans and data collection and interpretation will last up to 2 years; post processing, reports and publications will last about one more year)). 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 NCT05305937.

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 31 Mar 2022.

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