Diagnostic Scans for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: UNC Lineberger Comprehensive Cancer Center
Must not be taking: Antihistamines, Steroids
Disqualifiers: Claustrophobia, Metallic implants, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (CE- DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI) acquired as a part of a standard clinical workup.
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 data supports the effectiveness of the drug Iohexol 350 Mg/mL Injectable Solution, Omnipaque, Oraltag, Iohexol for diagnostic scans in breast cancer?
How does the drug iohexol differ from other treatments for breast cancer?
Iohexol is a contrast agent used in diagnostic imaging, which helps to enhance the visibility of internal structures in scans. Unlike traditional breast cancer treatments that focus on directly targeting cancer cells, iohexol is used to improve the accuracy of diagnostic scans, potentially aiding in the early detection and assessment of breast cancer.14567
Eligibility Criteria
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
I am a woman and at least 18 years old.
Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan
Suspected breast lesion based on prior imaging (BIRADS 4 or greater)
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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)
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Trial Timeline
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
Treatment Details
Interventions
- Iohexol 350 Mg/mL Injectable Solution (Contrast Agent)
Trial OverviewThe 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).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Contrast-enhanced digital breast tomosynthesis (CE-DBT)Experimental Treatment1 Intervention
Participants with known breast lesions will be imaged using contrast-enhanced digital breast tomosynthesis (CE-DBT) with Iohexol 350 mg I/mL.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
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Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
References
Iohexol in patients with previous adverse reactions to contrast media. [2019]Iohexol (Omnipaque) was used for enhancement of brain CT in 17 patients with previous adverse reactions to contrast media. Two of these patients also had cerebral angiography using iohexol. No premedication was given. The only adverse reaction was a skin reaction 24 hours after the iohexol injection, which might have been induced by the contrast medium or treatment with antibiotics. Five of the patients had repeated iohexol injections at different occasions without adverse reactions.
Phase II studies in urography, cardioangiography and cerebral angiography with iohexol. An evaluation of the clinical trial program and the clinical findings. [2013]The first experience in patients (phase II studies) with iohexol (Omnipaque) - a new non-ionic contrast medium - in intravenous urography (34 patients), cardioangiography (45 patients) and cerebral angiography (38 patents) is collectively reported. A non-comparative, multicentre design was used in all 3 applications. The objective was to assess the efficacy (the opacity to X-rays) and the tolerability of iohexol using routine contrast medium doses in a well defined adult population. No unexpected or severe reactions occurred in the 117 included or 9 excluded patients. Good efficacy was confirmed, and the contrast medium was well tolerated. The results warrant advancing iohexol into comparative phase III trials. The iohexol phase II studies and initial research in patients with contrast media in general are discussed.
Administration and dosage of iohexol, a nonionic contrast medium, for dynamic renal computed tomography. [2016]We investigated the optimal method of administering iohexol, which contains 300 mg iodine/ml (Omnipaque 300), a nonionic contrast medium, to maintain adequate renal contrast while reducing artifacts during dynamic CT scanning. In this study, 76 patients with renal disease received 10-50 ml of iohexol as follows: group I (14 patients), 20 ml injected as an intravenous bolus for 5 sec, followed by 30 ml intravenous drip infusion for 5 min; group II (18 patients), bolus of 20 ml injected for 5 sec; group III (13 patients), 20 ml diluted with sterile water (total volume 40 ml), and injected as a bolus for 8 sec; group IV (15 patients), 20 ml injection for 5 sec followed by intravenous drip infusion of 200 ml of Hartmann-Ringer's solution given at maximum speed; and group V (14 patients), 10 ml diluted with sterile water (total volume 20 ml) injected as a bolus for 5 sec. We found that corticomedullary differentiation was most distinct on the images obtained from group IV. We concluded that a lower concentration of iohexol (150 mg iodine/ml) given by intravenous fluid loading can provide superior CT images.
Myelography using iohexol (Omnipaque). [2015]Myelography was performed in 30 patients using iohexol (Omnipaque) 240 mg I/ml for lateral C1C2 injections, or iohexol 300 mg I/ml for lumbar injections. The dose varied from 3 to 10 ml. The patients were observed for 48 h for possible adverse reactions. A complete neurological examination was repeated 24h after the investigation, and EEG recordings 3-24h after the investigation. Adverse reactions occurred in 4 patients, minor EEG changes occurred in 1 patient, and slight changes in the neurological status were seen in 2 patients.
Embolization of arteriovenous malformation using freeze-dried iohexol as contrast material. [2019]We report a case of ruptured callosal arteriovenous malformation embolized preoperatively with freeze-dried iohexol (Omnipaque *) as the contrast medium for an alcohol-soluble liquid embolic material. Iohexol was dissolved in 15% alcohol to produce a 25% solution (100 mg/ml iodine), which proved adequate for monitoring with digital subtraction angiography.
Direct effects of contrast media on rat lungs. [2019]Despite the widespread use and the assumed safety of Omnipaque (iohexol) and 3% Gastrografin (meglumine diatrizoate) as contrast media for esophagography and computed tomography respectively, their effects on the lung if they are aspirated have never been studied. This information is important because such compounds may inadvertently enter the lungs during the diagnostic procedures. Twenty-four rats were injected intratracheally with 0.15 mL of one of three contrast agents (omnipaque, full-strength Gastrografin and 3% Gastrografin) or normal saline, which was used as a control. Radiographs were then obtained. Equal numbers from each experimental group were sacrificed after 5 minutes, 1 hour and 24 hours, and their lungs were examined pathologically. The rats injected with full-strength Gastrografin all died immediately of gross pulmonary edema. Neither Omnipaque nor 3% Gastrografin was fatal, but Omnipaque produced more edema and alveolar hemorrhage than either normal saline or 3% Gastrografin. Iohexol is, therefore, more irritating to the airways and the lung parenchyma than previously believed.
Use of iohexol in the radiographic diagnosis of ischemic bowel. [2019]This study evaluates the use of iohexol as a radiographic diagnostic contrast agent in normal animals and those with experimental bowel ischemia and obstruction. Eighteen rats and 12 rabbits were gavaged with iohexol in a dose of 7.5 mL/kg using concentrations of 140 mg I/mL (isotonic with blood) or 300 mg I/mL. In addition, four rabbits had intraperitoneal iohexol injection and three were given gastrografin gavage. Experimental groups included normal bowel controls, bowel injury induced by ischemia and alcohol contact, bowel obstruction by ligature, and intraperitoneal injection. Serial abdominal radiographs and plasma concentrations of iohexol were obtained. Iohexol remained stable throughout the gastrointestinal tract, retained its intensity, and was well visualized up to four days after administration. Bowel images were fair at concentrations of 140 mg I/mL and excellent at 300 mg I/mL. Gastrografin caused bowel distention and poor visualization related to dilution. It also precipitated in the stomach. Iohexol was rapidly absorbed from the peritoneal cavity and excreted by the kidneys, without causing peritonitis. Rat plasma iohexol levels were three times controls in obstructed bowel and 80 times controls if there was mucosal injury without perforation. Rabbit peak plasma levels were 30 times greater following intraperitoneal injection than with gastric gavage. These observations suggest that iohexol may be useful as a gastrointestinal contrast agent. Measuring plasma iohexol levels may be helpful in the evaluation of suspected bowel ischemia or perforation in the clinical setting.