Diagnostic Scans for Breast Cancer

Overseen By Doreen Steed, R.T.(R)(M)

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must not be taking: Antihistamines, Steroids

Disqualifiers: Claustrophobia, Metallic implants, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of imaging scans to determine which one increases doctors' confidence in evaluating breast lesions. The focus is on comparing contrast-enhanced digital breast tomosynthesis (CE-DBT) and contrast-enhanced MRI scans, both used in routine breast cancer check-ups. Women identified as potential candidates for a breast lesion after previous tests are suitable for this study. Participants will receive a special dye (Iohexol, also known as Omnipaque or Oraltag) before the CE-DBT scan to highlight any areas of concern in the breast tissue. As an Early Phase 1 trial, this research aims to understand how these imaging techniques function in people, offering participants a chance to contribute to pioneering advancements in breast cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diagnostic scan is safe for breast cancer evaluation?

Research shows that Iohexol, the injection used in this study, is usually safe for people. The FDA has already approved it for other imaging tests, confirming its well-known safety profile. However, some individuals might experience side effects, such as mild reactions like nausea or a warm sensation after the injection. More serious reactions are rare but can occur shortly after the injection begins. If you have allergies, especially to iodine, inform the research team, as Iohexol contains iodine. Always discuss any concerns with your doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Iohexol 350 mg/mL in contrast-enhanced digital breast tomosynthesis (CE-DBT) because it offers a new way to enhance imaging for breast cancer diagnosis. Unlike standard mammography, which can sometimes miss small or dense tissue abnormalities, CE-DBT with Iohexol provides a 3D view of the breast, making it easier to spot lesions. This technique could potentially lead to earlier and more accurate detection of breast cancer, which is crucial for effective treatment outcomes.

What evidence suggests that this trial's diagnostic scans could be effective for breast cancer?

Research shows that contrast-enhanced mammography, such as contrast-enhanced digital breast tomosynthesis (CE-DBT) using Iohexol, offers a promising method for detecting breast cancer. Studies have found these imaging techniques excel at identifying cancer in the breast. Early results suggest that using contrast, a special dye that clarifies images, aids in earlier cancer detection, particularly in women with dense breast tissue. Many patients prefer CE-DBT over methods like MRI, possibly due to greater comfort or superior image quality. Overall, CE-DBT with Iohexol appears to be an effective tool for detecting breast cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Rachel Hitt, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with suspected breast lesions (BIRADS 4+), who have had or will have a conventional breast MRI at UNC Hospitals within a three-month window around the research scan. Participants must be able to consent in writing and not be pregnant, as confirmed by tests or patient history.

Inclusion Criteria

Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan

I am a woman and at least 18 years old.

Suspected breast lesion based on prior imaging (BIRADS 4 or greater)

Exclusion Criteria

Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the UNC IRB SOP 4801)

Severe untreatable claustrophobia

Implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo contrast-enhanced digital breast tomosynthesis (CE-DBT) and conventional breast MRI imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Iohexol 350 Mg/mL Injectable Solution

Trial Overview The study aims to compare radiologist confidence when evaluating known breast lesions using two imaging techniques: contrast enhanced digital breast tomosynthesis (CE-DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI).

How Is the Trial Designed?

Group I: Contrast-enhanced digital breast tomosynthesis (CE-DBT) Experimental Treatment 1 Intervention

Participants with known breast lesions will be imaged using contrast-enhanced digital breast tomosynthesis (CE-DBT) with Iohexol 350 mg I/mL.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iohexol in patients with previous adverse reactions to contrast media. Holtås, S.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 24 rats, full-strength Gastrografin caused immediate death due to severe pulmonary edema, highlighting its dangerous effects if aspirated during medical procedures.

Omnipaque (iohexol) and 3% Gastrografin were not fatal but caused significant lung irritation, with Omnipaque leading to more edema and alveolar hemorrhage compared to normal saline, indicating it is more harmful to lung tissue than previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct effects of contrast media on rat lungs. Wells, HD., Hyrnchak, MA., Burbridge, BE.[2019]

In a study of 76 patients with renal disease, administering iohexol with intravenous fluid loading (200 ml of Hartmann-Ringer's solution) resulted in the best image quality during dynamic CT scanning, particularly enhancing corticomedullary differentiation.

Using a lower concentration of iohexol (150 mg iodine/ml) in combination with fluid loading improved CT imaging while potentially reducing the risk of artifacts, suggesting a safer and more effective method for renal contrast enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration and dosage of iohexol, a nonionic contrast medium, for dynamic renal computed tomography. Tsugaya, M., Sakagami, H., Mogami, T., et al.[2016]

Iohexol is a promising radiographic contrast agent for evaluating gastrointestinal conditions, showing excellent visualization in bowel imaging, especially at a concentration of 300 mg I/mL, compared to fair results at 140 mg I/mL.

The study demonstrated that iohexol is rapidly absorbed and excreted without causing adverse effects like peritonitis, and measuring its plasma levels could aid in diagnosing bowel ischemia or perforation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of iohexol in the radiographic diagnosis of ischemic bowel. Schwartzentruber, DJ., Billmire, DF., Cohen, M., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myelography using iohexol (Omnipaque). Peeters, F.[2015]

In a case of a ruptured callosal arteriovenous malformation, preoperative embolization was successfully performed using freeze-dried iohexol as a contrast medium, demonstrating its effectiveness in this context.

The iohexol was mixed with alcohol to create a solution suitable for monitoring during the procedure, indicating a novel approach to enhance imaging during embolization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embolization of arteriovenous malformation using freeze-dried iohexol as contrast material. Nagashima, H., Okudera, H., Hongo, K., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05625659

Comparison of Breast Cancer Screening With CESM to ... Aim 2: To evaluate the performance of CESM compared to DBT at the 1-year follow up for breast-cancer screening in women with dense breasts. Detailed Description.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10680079/

Contrast-Enhanced Mammography in Breast Cancer Screening Contrast-enhanced mammography (CEM) is a promising vascular-based breast imaging technique with high diagnostic performance in detecting breast cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X25004371

Contrast-Enhanced Mammography: Bridging the research ... Interim results have demonstrated that supplemental contrast imaging facilitate earlier cancer detection in women with dense breasts, without significant ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10996419/

Contrast-enhanced digital breast tomosythesis and ... Our paper suggests that patients prefer CE-DBT to MRI, adding further evidence in favour of contrast-enhanced mammographic techniques.

5. ajronline.org ajronline.org/doi/10.2214/AJR.24.32150

Digital Mammography, Tomosynthesis, and Contrast ... Data were summarized descriptively, including determination of corresponding effective doses. RESULTS. The breast density category was A in zero patients, B in ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/018956s099lbl.pdf

OMNIPAQUE™ (iohexol) Injection 140 180 240 300 350 140 ... contrast enhanced computed tomography of the abdomen. CONTRAINDICATIONS. OMNIPAQUE should not be administered to patients with a known hypersensitivity to ...

7. gehealthcare.com gehealthcare.com/-/jssmedia/GEHC/US/Files/Products/Contrast-Media/Omnipaque/omnipaque-uspi.pdf?srsltid=AfmBOoppir-MeA8ut-GKPmqAWgpc9B7kgXa2_gyxMxlXmy3sdLX59GnZ

omnipaque-uspi.pdf Risk Summary. Published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an ...

8. rxlist.com rxlist.com/omnipaque-drug.htm

Omnipaque (Iohexol Injection): Side Effects, Uses, Dosage, ... Omnipaque (Iohexol Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/018956s116%2C020608s049lbl.pdf

OMNIPAQUE (iohexol) oral solution - accessdata.fda.gov Most severe reactions develop shortly after the start of the injection. (within 3 minutes), but reactions can occur up to hours later. There is an increased ...

10. reference.medscape.com reference.medscape.com/drug/omnipaque-oraltag-iohexol-343760

Omnipaque, Oraltag (iohexol) dosing, indications, ... Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic ...