30 Participants Needed

Contrast-Enhanced Mammography for Breast Cancer

AS
CV
Overseen ByCaterina Vacchi-Suzzi, PhD
Age: 18+
Sex: Female
Trial Phase: Phase < 1
Sponsor: Alison Stopeck
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves imaging and contrast agents, it's best to discuss your medications with the research team to ensure there are no interactions.

What data supports the effectiveness of the drug Omnipaque 350mgI/mL Solution for Injection, Iohexol, Omnipaque 350?

Research shows that Iohexol, the active ingredient in Omnipaque, is effective in providing clear images for various types of medical imaging, such as urography, angiography, and myelography, with good tolerance and minimal adverse reactions in patients.12345

Is Omnipaque (Iohexol) generally safe for use in humans?

Omnipaque (Iohexol) is generally well-tolerated in humans, with fewer side effects compared to some other contrast media. However, it can cause minor skin reactions and, in rare cases, changes in neurological status or minor heart rate changes. In animal studies, it was found to be more irritating to the lungs than previously thought.23678

How does contrast-enhanced mammography differ from other breast cancer treatments?

Contrast-enhanced mammography (CEM) is unique because it uses an iodine-containing contrast medium to improve the visibility of breast tumors, which is not a feature of standard mammography. This method allows for better detection and characterization of lesions by producing enhanced images through a combination of low and high energy exposures.910111213

What is the purpose of this trial?

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.Participation may last up to 18 weeks.Study procedures for this research are:* Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery.* Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent* Let the research team record information from your medical record related to your condition and the treatment you receive.* Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.

Research Team

Alison Stopeck, MD | Stony Brook Cancer ...

Alison Stopeck, MD

Principal Investigator

Stony Brook Cancer Center

Eligibility Criteria

This trial is for individuals with early-stage, invasive breast cancer who are planning to undergo at least four cycles of neoadjuvant chemotherapy before surgery. Participants will have mammograms using a contrast agent during/after chemo but before surgery.

Inclusion Criteria

I am scheduled for at least 4 rounds of chemotherapy before surgery.
I have been diagnosed with advanced breast cancer, regardless of hormone or HER2 status.

Exclusion Criteria

Pregnancy
Allergy/sensitivity to contrast agent
I have diabetes.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy, with imaging occurring after every 4-6 cycles

12-16 weeks
1-2 imaging visits

Imaging and Surgery Preparation

Participants undergo CEDM + CEDBT imaging and prepare for definitive breast surgery

2 weeks
1-2 imaging visits

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

  • Omnipaque 350mgI/mL Solution for Injection
Trial Overview The study compares contrast-enhanced digital mammography (CEDM) and digital breast tomosynthesis (CEDBT) against MRI in predicting the effectiveness of pre-surgery chemotherapy on eliminating cancer cells.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CEDM + CEDBTExperimental Treatment3 Interventions
Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alison Stopeck

Lead Sponsor

Trials
4
Recruited
220+

Findings from Research

In a phase II study involving 117 patients across three different applications (urography, cardioangiography, and cerebral angiography), iohexol (Omnipaque) demonstrated good efficacy in providing X-ray opacity and was well tolerated without any unexpected severe reactions.
The positive results from these initial studies support the advancement of iohexol into phase III trials for further evaluation as a contrast medium.
Phase II studies in urography, cardioangiography and cerebral angiography with iohexol. An evaluation of the clinical trial program and the clinical findings.Andrew, E., Sveen, K., Renaa, T., et al.[2013]
In a study involving 17 patients with a history of adverse reactions to contrast media, iohexol was used for brain CT enhancement without premedication, resulting in only one mild skin reaction after 24 hours.
Five patients received multiple iohexol injections on different occasions without experiencing any adverse reactions, suggesting that iohexol may be a safe option for patients with previous contrast media sensitivities.
Iohexol in patients with previous adverse reactions to contrast media.Holtås, S.[2019]
In a study involving 30 patients undergoing myelography with iohexol, adverse reactions were observed in 4 patients, indicating a low but notable risk associated with the procedure.
The neurological status of 2 patients showed slight changes, and minor EEG changes were noted in 1 patient, suggesting that while the procedure is generally safe, monitoring for neurological effects is important.
Myelography using iohexol (Omnipaque).Peeters, F.[2015]

References

Phase II studies in urography, cardioangiography and cerebral angiography with iohexol. An evaluation of the clinical trial program and the clinical findings. [2013]
Iohexol in patients with previous adverse reactions to contrast media. [2019]
Myelography using iohexol (Omnipaque). [2015]
Comparison of low-osmolar contrast media in paediatric cardiac angiography. [2015]
Iohexol in coronary angiography. A double blind investigation. [2019]
Direct effects of contrast media on rat lungs. [2019]
Iohexol compared to meglumine-Ca-metrizoate in common carotid angiography. A randomized double blind cross-over study in man. [2019]
[Clinical analysis of drug eruption due to iohexol (Omnipaque)]. [2013]
Technique, protocols and adverse reactions for contrast-enhanced spectral mammography (CESM): a systematic review. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Contrast-enhanced digital mammography: initial clinical experience. [2022]
Low energy mammogram obtained in contrast-enhanced digital mammography (CEDM) is comparable to routine full-field digital mammography (FFDM). [2022]
[Use of contrast-enhanced mammography for diagnosis of breast cancer]. [2023]
13.Korea (South)pubmed.ncbi.nlm.nih.gov
Contrast-enhanced spectral mammography: comparison with conventional mammography and histopathology in 152 women. [2018]
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