Patient perspectives on infection prevention and control in cancer care: a survey of knowledge and attitudes among persons with cancer and their next of kin.

BACKGROUND: With the growing prevalence of antimicrobial resistance, there may be a need to strengthen infection prevention and control (IPC) measures in cancer care. When developing clinical guidelines, it is important to incorporate patient perspectives. AIM: To determine the knowledge of, and attitudes towards, IPC among persons with cancer and their next of kin in Norway. METHODS: Through discussions in expert panels and a pilot study, a survey was developed consisting of 13 knowledge statements to be judged true/false and 40 attitude items to be judged using a Likert scale and was sent to a panel of people with cancer experience on August 22nd, 2023. The mean correct responses and attitude scores were reported. FINDINGS: Of 551 respondents, the mean correct response to IPC-related knowledge questions was 79% (95% confidence interval: 78-80). Respondents were most knowledgeable about hand hygiene (99%, 546/551), but least knowledgeable about its role in preventing antibiotic resistance (41%, 225/551). Strong support was noted for IPC, especially within the patient responsibilities theme, with a mean score of 4.83. However, there was a notable reluctance towards some selected intrusive IPC measures, such as reducing contact with close relations. CONCLUSION: This survey revealed a high level of knowledge and attitudes that support the importance of IPC among persons with cancer in Norway and their next of kin. We recommend including patient perspectives in future development of IPC guidelines.

A new liposomal liver-specific contrast agent for CT: first human phase-I clinical trial assessing efficacy and safety.

In this first clinical trial liposome-encapsulated iodixanol, CT particles (CTP) were studied. The aims of the present trial were to assess the efficacy of CTP in CT and to determine the safety of different doses of CTP. A total of 47 healthy volunteers were enrolled in the present study. The CTP was administered at doses 10, 30, 70 and 100 mg encapsulated I/kg bw. Efficacy was assessed using single-slice CT of the abdomen and evaluated by dose-response attenuation curves over time in liver, spleen, and abdominal vessels. Safety was assessed by blood tests, clinical examinations and recording of subjective adverse events (AE). The attenuations in liver tissue increased with the dose and maximal values above baseline were 20, 39 and 45 HU at the doses 30, 70 and 100 mg encapsulated I/kg bw, respectively. Maximal increases were seen 12.5 min after contrast administration. As for liver, the attenuations in spleen increased with the dose, but higher attenuations were obtained. In early images clinically significant enhancement was seen in abdominal vessels. Mild and moderate subjective AE were encountered at the doses 70 and 100 mg encapsulated I/kg bw. The CTP is efficacious in enhancing hepatic and splenic tissues and in early imaging of abdominal vessels. Adverse event precludes a clinical use of CTP in the current formulation.

Pulmonary MR angiography with ultrasmall superparamagnetic iron oxide particles as a blood pool agent and a navigator echo for respiratory gating: pilot study.

In nine healthy adult volunteers, pulmonary magnetic resonance angiography was performed with the blood pool agent NC100150 injection combined with respiratory gating with a navigator echo. With increasing doses of the contrast agent, higher signal intensities and vessel branch order visualization were achieved. No motion artifacts were seen. The blood pool agent NC100150 injection in combination with respiratory navigator gating permitted acquisition of high-quality MR angiograms of the pulmonary vasculature during continuous breathing.

Abdominal vessel enhancement with an ultrasmall, superparamagnetic iron oxide blood pool agent: evaluation of dose and echo time dependence at different field strengths.

RATIONALE AND OBJECTIVES: The purpose of the study was to determine the dose and echo time dependence of abdominal vessel enhancement at magnetic resonance (MR) imaging after injection of a blood pool contrast agent at two field strengths. MATERIALS AND METHODS: Sixteen healthy volunteers received NC100150 Injection at three dose levels (1.0 mg, 2.5 mg, and 4.0 mg of iron per kilogram of body weight). Images of the aorta and inferior vena cava (IVC) were obtained at 0.5 or 1.5 T. Four sequences with varying echo times were used with each subject. Signal intensities were recorded from the aorta, IVC, vessel vicinity, air, and a marker outside the patient. Contrast-to-noise ratios (CNRs) were calculated for the vessels. Aortic delineation was subjectively evaluated. RESULTS: Images with the highest mean vessel signal intensities, subjectively assessed as satisfactory for aortic delineation, were obtained with 2.5-4.0 mg of iron per kilogram of body weight at both field strengths. The highest CNR was found with 4.0 mg of iron per kilogram of body weight at 1.5 T. An increase in echo time caused larger signal intensity loss at larger dose levels. The signal intensity from the IVC was higher than that of the aorta at all dose levels, echo times, and field strengths. CONCLUSION: NC100150 Injection is an efficient T1-reducing agent at both 0.5 and 1.5 T. A positive dose response for CNR of the aorta and IVC was seen at 1.5 T.

Evaluation of the clinical safety of gadodiamide injection, a new nonionic MRI contrast medium for the central nervous system: a European perspective.

Gadodiamide injection is a new nonionic paramagnetic, extracellular contrast medium. Its safety at a dose of 0.1 mmol/kg body weight was evaluated in a large European multicentre trial on adults referred for contrast-enhanced MRI of the central nervous system. Safety analysis was performed on 2102 patients, in whom adverse events during and up to 24 h after injection were recorded. Adverse events related or possibly related to gadodiamide injection were observed in 102 patients. Injection-associated reactions classified as discomfort (sensation of heat or coldness, pain or pressure at the injection site) occurred in 37 patients (1.8%) and other adverse events (e.g. headache, nausea) were observed in 65 patients (3.1%). No serious adverse event was reported. Efficacy analysis, performed on 2273 patients, and based on comparison of T1- and T2-weighted images before and T1-weighted images after injection showed that more diagnostic information was obtained after gadodiamide injection in 1424 (62.6%) patients: management of 386 (17.0%) patients was affected by the new information given and that a new diagnosis was made in 755 (33.3%) patients. Gadodiamide injection was shown to be safe and well tolerated. It represents a nonionic alternative to the current products for MRI of the central nervous system.

[Clinical evaluation of the tolerability of gadodiamide, a new nonionic contrast agent in MRI of the central nervous system]. / Evaluation clinique de la tolérance du gadodiamide, nouvel agent de contraste non-ionique pour l'IRM du système nerveux central.

Gadodiamide injection (Gd-DTPA-BMA) is a new non-ionic paramagnetic contrast agent for which the safety at the dose 0.1 mmol/kg was evaluated during a European multicentre study on a large population of adult patients who had an MR examination of the central nervous system with contrast medium. The safety analysis was performed on 2,102 patients by recording the adverse events observed during injection and up to 24 hours after the injection. Adverse events due or probably due to gadodiamide injection were observed in 102 patients (4.4%) with injection-site associated discomfort (heat, coldness, pain at the injection site) in 37 patients (1.8%) and adverse events other than discomfort (headache, nausea, vomiting) in 35 patients (3.1%). No adverse events of severe intensity or death were reported during the trial. Gadodiamide injection was shown to be safe and well tolerated and represents a non-ionic alternative to the current products in the field of MR imaging of the central nervous system.

Gadodiamide injection at 0.1 and 0.3 mmol/kg body weight: a phase III double-blind, parallel, randomised clinical investigation of known or suspected central nervous system lesions at 1.5 T.

We studied 78 patients with clinically suspected central nervous system abnormalities (66 intracranial, 12 spinal) by MRI before and after administration of the nonionic contrast medium gadodiamide injection. A parallel, double-blind, randomised design was followed. Two dosages were used: 38 patients underwent studies with 0.1 mmol/kg body weight (b.w.) and 40 with 0.3 mmol/kg b.w. MRI showed abnormalities in 36 of the 38 patients receiving the lower dose and 39 of the 40 patients receiving the higher dose. In 3 patients from each group more lesions were seen following injection than before. The contrast medium improved the delineation of abnormal structures and assessment of tumour size and increased their signal intensity indices in both groups, but especially at the higher dose. Administration of gadodiamide injection provided more diagnostic information in about 75% of the patients, independently of the dose. There were no reports of discomfort, but 7 patients reported adverse events considered unrelated to the gadodiamide injection. The two doses were found to be equally safe and efficient for diagnosis.

[Oral magnetic particles as an MR contrast medium for the gastrointestinal tract]. / Orale magnetische Partikel als MR-Kontrastmittel für den Gastrointestinaltrakt.

The authors summarise their experience of four clinical studies with a negative oral contrast agent for magnetic resonance imaging of the abdomen and pelvis. 140 patients were enrolled in the studies. These were partly comparative studies pre- and post-contrast, partly at 0.5 and 1.5 T, partly pre-injection and post-injection of glucagon. All patients received 800 ml of a suspension of oral magnetic particles "OMP". The distribution of this contrast agent was homogeneous throughout the entire GI tract. A complete or partial signal void was observed in all patients in T1, T2-, and intermediately weighted images. Generally, diagnostic information was higher after contrast. Artifacts caused by peristalsis and movement of the diaphragm were fewer after contrast. After contrast metallic artifacts were observed in a minority of patients. Adverse events after contrast were minimal; they included nausea and vomiting.

Gadodiamide injection and gadopentetate dimeglumine. A double-blind study in MR imaging of the CNS.

A double-blind, randomized parallel phase III study in MR imaging of the central nervous system was conducted to compare the safety and diagnostic utility of gadodiamide injection and gadopentetate dimeglumine at a dose of 0.1 mmol/kg b.w. in 60 adult patients. Seven patients in the gadodiamide injection group experienced 10 adverse events, 5 of the events possibly related to the contrast agent. In the gadopentetate dimeglumine group 5 patients reported 3 contrast agent-related adverse events out of 8 events. All events were transient and required no treatment. Seven incidents of patient discomfort, and some minor changes in vital signs and laboratory parameters were of no clinical concern. Contrast enhancement was observed in 60% and 44% of the patients with structural abnormalities in the gadodiamide injection group and gadopentetate dimeglumine group, respectively. No difference in overall efficacy was observed. Gadodiamide injection was found to be a safe and effective contrast agent.

Oral magnetic particles in MR imaging of the abdomen and pelvis.

Two phase 2 clinical trials of an oral superparamagnetic contrast agent for enhancement on magnetic resonance images of the intestine were performed. In trial 1, 31 male patients with cancer of the testis underwent follow-up examinations of the abdomen at 0.5 and 1.5 T after oral administration of magnetic particles. In trial 2, 31 female patients with pelvic and lower abdominal disease were examined at 1.5 T after administration of the contrast material. The patients each ingested 800 mL of contrast material over approximately 2 hours. Concentrations of 0.25 and 0.5 g/L did not induce blurring or metallic artifacts. Distribution was homogeneous through the gastrointestinal tract. In all patients, a loss of signal intensity was observed on proton density-, T1-, and T2-weighted images. The diagnostic information from postcontrast images in trial 2 was greater in 16 patients (52%). Contrast enhancement was independent of field strength; no major side effects were observed. Artifacts from moving bowels were less troublesome, and delineation of intraabdominal and pelvic organs was better with the use of oral magnetic particles.