Maintenance of Antibody Response in Egyptian Healthcare Workers Vaccinated with ChAdOx1 nCoV-19 Vaccine during Delta and Omicron Variants Pandemic: A Prospective Study.

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a constantly evolving virus, resulting in an increased burden on the existing COVID-19 vaccines. Healthcare workers (HCWs) are the first line of defense against the coronavirus disease 2019 (COVID-19) pandemic and have been prioritized among the risk categories receiving the COVID-19 vaccine. This work aimed to investigate the maintenance of antibody response of the Oxford−AstraZeneca vaccine (ChAdOx1/nCoV-19). Methods: Anti-spike immunoglobulin G (IgG) was measured at baseline point (immediately prior to vaccination) and 12- and 24-week (w) points following vaccination. Adverse reactions to the vaccine were reported. Participants were followed up for the incidence of COVID-19 during the 12 w interval between vaccination doses for 24 w after the second dose. Results: A total of 255 HCWs participated in the study. Prior to vaccination, 54.1% experienced COVID-19, 88.2% were seropositive after the first dose, while seropositivity reached 95.7% after the second dose. Following the first and second doses, the anti-spike IgG serum level was significantly higher in subjects with past COVID-19 than in others (p < 0.001 and =0.001, respectively). Conclusions: The Oxford−AstraZeneca vaccine is generally safe and provides a highly effective long-term humoral immune response against the Delta and Omicron variants of SARS-CoV-2.

Predictors of the Therapeutic Response to Intralesional Bivalent HPV Vaccine in Wart Immunotherapy.

Variable intralesional immunotherapies have recently been proposed as a means of achieving a successful eradication of recurrent and recalcitrant human papillomavirus (HPV)-induced cutaneous and anogenital warts. The bivalent HPV vaccine is one of the newly proposed immunotherapeutic agents. We investigated the role of interleukin-4 (IL-4) and interferon-gamma (IFN-γ) as ex vivo immunologic predictors to estimate the response to the bivalent HPV vaccine as a potential immunotherapy for cutaneous and anogenital warts. Heparinized blood samples were withdrawn from forty patients with multiple recurrent recalcitrant cutaneous and anogenital warts and forty matched healthy control subjects. Whole blood cultures were prepared with and without bivalent HPV vaccine stimulation. Culture supernatants were harvested and stored for IL-4 and IFN-γ measurements using an enzyme-linked immunosorbent assay. A comparative analysis of IL-4 and IFN-γ levels in culture supernatants revealed a non-significant change between the patient and control groups. The bivalent HPV vaccine stimulated cultures exhibited a non-significant reduction in IL-4 levels within both groups. IFN-γ was markedly induced in both groups in response to bivalent HPV vaccine stimulation. The bivalent HPV vaccine can give a sensitive IFN-γ immune response ex vivo, superior to IL-4 and sufficient to predict both the successful eradication of HPV infection and the ultimate clearance of cutaneous and anogenital warts when the bivalent HPV vaccine immunotherapy is applied.

Validity and Reproducibility of the ADNEX MR Scoring System in the Diagnosis of Sonographically Indeterminate Adnexal Masses.

BACKGROUND: The diagnosis of sonographically indeterminate adnexal masses (AM) signifies a major challenge in clinical practice. Early detection and characterization have increased the need for accurate imaging evaluation before treatment. PURPOSE: To assess the validity and reproducibility of the ADNEX MR Scoring system in the diagnosis of sonographically indeterminate AM. STUDY TYPE: A prospective multicenter study. POPULATION: In all, 531 women (mean age, 44 ± 11.2 years; range, 21-79 years) with 572 sonographically indeterminate AM. FIELD STRENGTH/SEQUENCE: 1.5T/precontrast T1 -weighted imaging (WI) fast spin echo (FSE) (in-phase and out-of-phase, with and without fat suppression); T2 -WI FSE; diffusion-WI single-shot echo planner with b-values of 0 and 1000 s/mm2 ; and dynamic contrast-enhanced perfusion T1 -WI liver acquisition with volume acceleration (LAVA). ASSESSMENT: All MRI examinations were evaluated by three radiologists, and the AM were categorized into five scores based on the ADNEX MR Scoring system. Score 1: no AM; 2: benign AM; 3: probably benign AM; 4: indeterminate AM; 5: probably malignant AM. Histopathology and imaging follow-up were used as the standard references for evaluating the validity of the ADNEX MR Scoring system for detecting ovarian malignancy. STATISTICAL TESTS: Four-fold table test, kappa statistics (κ), and receiver operating characteristic (ROC) curve. RESULTS: In all, 136 (23.8%) AM were malignant, and 436 (76.2%) were benign. Of the 350 AM classified as score 2, one (0.3%) was malignant; of the 62 AM classified as score 3, six (9.7%) were malignant; of the 73 AM classified as score 4, 43 (58.9%) were malignant; and of the 87 AM categorized as score 5, 86 (98.9%) were malignant. The best cutoff value for predicting malignant AM was score >3 with sensitivity and specificity of 92.9% and 94.9%, respectively. The interreader agreement of the ADNEX MR Scoring was very good (κ = 0.861). DATA CONCLUSION: The current study supports the high validity and reproducibility of the ADNEX MR Scoring system for the diagnosis of sonographically indeterminate AM. LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY STAGE: 2.

Comparison of O-RADS, GI-RADS, and IOTA simple rules regarding malignancy rate, validity, and reliability for diagnosis of adnexal masses.

OBJECTIVE: The American College of Radiology (ACR) recently published the ovarian-adnexal reporting and data system (O-RADS) to provide guidelines to physicians who interpret ultrasound (US) examinations of adnexal masses (AM). This study aimed to compare the O-RADS with two other well-established US classification systems for diagnosis of AM. METHODS: This retrospective multicenter study between May 2016 and December 2019 assessed consecutive women with AM detected by the US. Five experienced consultant radiologists independently categorized each AM according to O-RADS, gynecologic imaging reporting and data system (GI-RADS), and international ovarian tumor analysis (IOTA) simple rules. Pathology and adequate follow-up were used as reference standards for calculating the validity of three US classification systems for diagnosis of AM. Kappa statistics were used to assess the inter-reviewer agreement (IRA). RESULTS: A total of 609 women (mean age, 48 ± 13.7 years; range, 18-72 years) with 647 AM were included. Of the 647 AM, 178 were malignant and 469 were benign. Malignancy rates were comparable to recommended rates by previous literature in O-RADS and IOTA, but higher in GI-RADS. O-RADS had significantly higher sensitivity for malignancy than GI-RAD and IOTA (p = 0.003 and 0.0007, respectively), but non-significant slightly lower specificity (p > 0.05). O-RADS, GI-RADS, and IOTA showed similar overall IRA (κ = 0.77, 0.69, and 0.63, respectively) with a tendency toward higher IRA with O-RADS than with GI-RADS and IOTA. CONCLUSIONS: O-RADS compares favorably with GI-RADS and IOTA. O-RADS had higher sensitivity than GI-RADS and IOTA simple rules with relatively similar specificity and reliability. KEY POINTS: • The malignancy rates were comparable to recommended rates by previous literature in O-RADS and IOTA, but higher in GI-RADS. • The O-RADS had significantly higher sensitivity for malignancy than GI-RADS and IOTA (96.8% vs 92.7% and 92.1%; p = 0.003 and 0.0007, respectively), but non-significant slightly lower specificity (92.8% vs 93.6% and 93.2%, respectively; p > 0.05). • The O-RADS, GI-RADS, and IOTA showed similar overall inter-reviewer agreement (IRA) (κ = 0.77, 0.69, and 0.63, respectively), with a tendency toward higher IRA with O-RADS than with GI-RADS and IOTA.

The validity and reproducibility of the thyroid imaging reporting and data system (TI-RADS) in categorization of thyroid nodules: Multicentre prospective study.

PURPOSE: To assess diagnostic validity and reproducibility of Thyroid Imaging Reporting and Data System (TI-RADS) for interpretation of thyroid nodules by thyroid ultrasonography (US). METHOD: A prospective multicentre study initially included 557 patients with clinically suspected thyroid nodules. After exclusion, a final cohort of 380 patients with 948 thyroid nodules detected by US were enrolled. Based on American College of Radiology (ACR) TI-RADS, three radiologists analysed all US examinations independently and assigned a TI-RADS category to each thyroid nodule. The final diagnosis was based on cytology which was used as reference standard for calculating diagnostic performance of TI-RADS for predicting malignant thyroid nodules. The Fleiss and weighted kappa (κ) statistics were applied to assess inter-observer agreement of morphological features and TI-RADS scoring results for thyroid nodules. Additionally, we made a simple screening among referring clinicians to assess the clinical response to application of TI-RADS. RESULTS: A total of 948 thyroid nodules were evaluated; 136 (14.3%) were malignant, and 812 (85.7%) were benign. The papillary carcinoma was the most common malignant thyroid nodules (81.6%). The best cut-off value for predicting malignant thyroid nodules was > TR3. On a lesion-based analysis, the TI-RADS had a sensitivity, specificity, and an accuracy of 98.3%, 90.9%, and 92.1%, respectively when regarding those thyroid nodules classified as > TR3 for predicting malignancy. The inter-observer agreement of the TI-RADS category was good (κ = 0.636). Ninety percent of referring clinicians accept TI-RADS. CONCLUSIONS: TI-RADS improves diagnostic performance of US for predicting malignant thyroid nodules with high validity and high reproducibility.

68Ga-PSMA-11 PET/CT in newly diagnosed prostate cancer: diagnostic sensitivity and interobserver agreement.

PURPOSE: To determine the diagnostic sensitivity and interobserver agreement of Gallium 68-prostate-specific membrane antigen positron emission tomography/computed tomography (68Ga-PSMA-11 PET/CT) imaging for diagnosis and staging of patients with newly diagnosed prostate cancer (PC). MATERIALS AND METHODS: One hundred and seventy-three men (mean age, 68 ± 7.7 years; range 46-84 years) with newly diagnosed, untreated PC were enrolled in this prospective study between January 2017 and August 2018. All patients underwent a 68Ga-PSMA-11 PET/CT examination. For each patient, we determined the disease stage, the Gleason score, and the maximum standardized uptake value (SUVmax) for primary prostatic tumor and extraprostatic metastases. The diagnostic sensitivity and interobserver agreement of 68Ga-PSMA-11 PET/CT for diagnosis and staging of PC were established by histopathology as the reference standard. RESULTS: 68Ga-PSMA-11 PET/CT examinations were interpreted as positive for PC in 166 of 173 patients (101 patients had primary prostatic tumor only, two patients had extraprostatic metastases only and 63 patients had combined lesions). The sensitivity of 68Ga-PSMA-11 PET/CT examination in the diagnosis of PC was 96%. 68Ga-PSMA-11 PET/CT produced a significant change of stage in 28.6% patients with an upstage in 17.9% patients and a downstage in 10.7% patients. The interobserver agreements were almost good to perfect (k = 0.63-0.89) for visual image interpretation, SUVmax measurement, and tumor staging. CONCLUSION: 68Ga-PSMA-11 PET/CT is a valuable tool with high diagnostic sensitivity (96%) and high reproducibility for diagnosis and staging of patients with newly diagnosed PC.

68Ga-PSMA PET/CT in Patients with Rising Prostatic-Specific Antigen After Definitive Treatment of Prostate Cancer: Detection Efficacy and Diagnostic accuracy.

RATIONALE AND OBJECTIVES: 68Ga-prostate-specific membrane antigen-11 (68Ga-PSMA-11) is a recently developed positron emission tomography (PET) tracer that can detect prostate cancer (PC) relapses and metastases with high contrast resolution. The aim of this study was to assess the detection efficacy and diagnostic accuracy of 68Ga-PSMA PET/CT image in patients with rising prostatic-specific antigen (PSA) after treatment of PC. MATERIALS AND METHODS: The present prospective study included 188 patients who exhibited rising of PSA level on a routine follow-up examination after definitive treatment of PC. All patients underwent a 68Ga-PSMA PET/CT examination. For each patient, we determined the disease stage, the Gleason score, and the maximum standardized uptake value of the local recurrence and extraprostatic metastases. The detection efficacy and diagnostic accuracy of 68Ga-PSMA PET/CT were established by histopathology and clinical and imaging follow-up as the reference standards. RESULTS: 68Ga-PSMA PET/CT detected tumour relapse in 165 patients (35 patients had local recurrence, 106 patients had extraprostatic metastases, and 24 patients had combined lesions). The sensitivity, specificity, and accuracy values of 68Ga-PSMA PET/CT examination in the detection of PC recurrence were 98.8%, 100%, and 98.8%, respectively. 68Ga-PSMA PET/CT revealed an overall detection rate of 87.8% (165/188) in patients with rising PSA (median of 2.2 ng/mL, and range of 0.01-70 ng/mL). CONCLUSION: 68Ga-PSMA PET/CT is a valuable tool for the detection of PC local recurrence or extraprostatic metastases following rising PSA levels after primary definitive therapy and should be incorporated during routine work-up.

Diagnostic performance of 18F-FDG PET/CT and whole-body MRI before and early after treatment of multiple myeloma: a prospective comparative study.

OBJECTIVE: To determine the diagnostic accuracy of WB-MRI and 18F-FDG PET/CT in detecting infiltration pattern, disease activity, and response to treatment in patients with multiple myeloma (MM). MATERIALS AND METHODS: Fifty-six patients with confirmed MM were included in the present study for pre-treatment evaluation. Among these individuals, 22 patients were available for the post-treatment evaluation of response to therapy. All patients were imaged with both WB-MRI and 18F-FDG PET/CT. All radiographic findings of infiltration pattern, disease activity, and response to therapy were compared. The diagnostic performance of both modalities was estimated using bone marrow aspirate and biopsy as the reference test. RESULTS: For detection of active myelomatous tissue at diagnosis, WB-MRI achieved higher sensitivity (94%) than 18F-FDG PET/CT (75%) (p = 0.0039), whereas both modalities achieved the same specificity (80%). For detection of residual myelomatous tissue after treatment, 18F-FDG PET/CT achieved higher specificity (86%) than WB-MRI (43%) (p = 0.0081), whereas both modalities achieved the same sensitivity (75%). CONCLUSION: WB-MRI is more sensitive than 18F-FDG PET/CT in the diagnosis of MM before treatment; however, 18F-FDG PET/CT is more specific than WB-MRI in detecting residual involvement in treated patients.