ABSTRACT
The expression status of human epidermal growth factor receptor 2 (HER2) in cancer predicts response to HER2-targeted therapy. Therefore, its accurate determination is of utmost importance. In recent years, there has been an increase in research on noninvasive techniques for molecular imaging, as this method offers the advantages of a more accurate determination of HER2 status without the need for multiple biopsies. The technetium-labeled single-domain antibody RAD201, previously known as 99mTc-NM-02, has been shown to be safe for use in breast cancer imaging with reasonable radiation doses, favorable biodistribution, and imaging characteristics. METHODS: A total of six HER2-positive, heavily pretreated patients with different cancer types aged between 42 and 69 years (5 women and 1 man; the median age of 55.5) have been examined. In six of seven scans, the patients were administered 500 ml of Gelofusine® solution (40 mg/ml) for radiation protection before the tracer injection (434 ± 42 MBq). Planar scans were acquired with the patient supine at 10 min, 60 min, 160 min, 20 h, and 24 h after injection. A CT scan was acquired at 95 min, followed by local tomographic SPECT imaging. RESULTS: One patient was scanned twice with RAD201, 3 months apart, resulting in a total of seven scans for six patients. Here, we show that the use of RAD201 in our patient group shows the same favorable biodistribution as in a previous study with RAD201 (NCT04040686) and that the radiation dose to the critical organ kidney can be reduced by the application of the plasma expander Gelofusine® by almost 50%. CONCLUSION: RAD201 appears safe for use in humans and is a promising noninvasive tool for discriminating HER2 status in metastatic (breast) cancer, regardless of ongoing HER2-targeted antibody treatment.
Subject(s)
Breast Neoplasms , Single-Domain Antibodies , Male , Humans , Female , Adult , Middle Aged , Aged , Single-Domain Antibodies/metabolism , Tissue Distribution , Polygeline/metabolism , Tomography, Emission-Computed, Single-Photon , Breast Neoplasms/pathology , Tomography, X-Ray ComputedABSTRACT
Esta Guía de Práctica Clínica responde a preguntas clínicas sobre seguridad en la elección de fluido (cristaloide, coloide o Hidroxietilalmidón 130) en pacientes que precisan restauración volémica en el periodo perioperatorio de cirugía no cardiaca. A partir del resumen de la evidencia, se elaboraron las recomendaciones siguiendo la metodología GRADE. En esta población se sugiere la fluidoterapia basada en la administración de cristaloides, (recomendación débil, calidad de la evidencia baja). En las situaciones en las que la restauración volémica no se alcance sólo con cristaloides, se sugiere utilizar coloides sintéticos (Hidroxietilalmidón 130 o gelatina fluida modificada) en lugar de Albúmina 5% (recomendación débil, calidad de la evidencia baja). La elección y dosificación de coloide deberán basarse en las características del producto, comorbilidad del paciente y experiencia del anestesiólogo (AU)
The present Clinical practice guide responds to the clinical questions about security in the choice of fluid (crystalloid, colloid or hydroxyethyl starch 130) in patients who require volume replacement during perioperative period of non-cardiac surgeries. From the evidence summary, recommendations were made following the GRADE methodology. In this population fluid therapy based on crystalloids is suggested (weak recommendation, low quality evidence). In the events where volume replacement is not reached with crystalloids, the use of synthetic colloids (hydroxyethyl starch 130 or modified fluid gelatin) is suggested instead of 5% albumin (weak recommendation, low quality evidence). The choice and dosage of the colloid should be based in the product characteristics, patient comorbidity and anesthesiologist's experience (AU)
Subject(s)
Humans , Male , Female , Thoracic Surgery/methods , Colloids/administration & dosage , Fluid Therapy/methods , Pharmaceutical Preparations/administration & dosage , Communicable Diseases/pathology , Communicable Diseases/transmission , Anesthetics, Intravenous/administration & dosage , Anesthetics, Intravenous/metabolism , Polygeline/metabolism , Spain/ethnology , Thoracic Surgery/standards , Colloids/metabolism , Fluid Therapy , Pharmaceutical Preparations/metabolism , Communicable Diseases/genetics , Communicable Diseases/metabolism , Anesthetics, Intravenous/supply & distribution , Anesthetics, Intravenous/toxicity , PolygelineABSTRACT
Polygeline is a polymer of urea and polypeptides derived from degraded gelatin. The mean molecular weight of the polygeline molecules is 35000 with a range of 5000 to 50000. It is available as a 3.5 percent solution in 500 ml plastic bottles (Haemaccel) and in addition to the polygeline there is sodium, potassium, calcium and chloride ions. Polygeline is readily excreted in the urine so has a short half life of about 3-6 hours. This half life increases in patients with impaired renal function to about 16 hours. Polygeline is used in the initial management of hypovolaemia where its dose is limited by the degree of haemodilution which can be tolerated by the patient. In adults this amounts to about 1,500 ml. Histamine release has been reported with polygeline and this may result in hypotension, bronchospasm and skin rash. Recent alterations in its preparation have reduced the incidence of reactions to 0.78 percent.
