Comparison of conventional and Si-photomultiplier-based PET systems for image quality and diagnostic performance.

BACKGROUND: A new generation of positron emission tomography with computed tomography (PET-CT) was recently introduced using silicon (Si) photomultiplier (PM)-based technology. Our aim was to compare the image quality and diagnostic performance of a SiPM-based PET-CT (Discovery MI; GE Healthcare, Milwaukee, WI, USA) with a time-of-flight PET-CT scanner with a conventional PM detector (Gemini TF; Philips Healthcare, Cleveland, OH, USA), including reconstruction algorithms per vendor's recommendations. METHODS: Imaging of the National Electrical Manufacturers Association IEC body phantom and 16 patients was carried out using 1.5 min/bed for the Discovery MI PET-CT and 2 min/bed for the Gemini TF PET-CT. Images were analysed for recovery coefficients for the phantom, signal-to-noise ratio in the liver, standardized uptake values (SUV) in lesions, number of lesions and metabolic TNM classifications in patients. RESULTS: In phantom, the correct (> 90%) activity level was measured for spheres ≥17 mm for Discovery MI, whereas the Gemini TF reached a correct measured activity level for the 37-mm sphere. In patient studies, metabolic TNM classification was worse using images obtained from the Discovery MI compared those obtained from the Gemini TF in 4 of 15 patients. A trend toward more malignant, inflammatory and unclear lesions was found using images acquired with the Discovery MI compared with the Gemini TF, but this was not statistically significant. Lesion-to-blood-pool SUV ratios were significantly higher in images from the Discovery MI compared with the Gemini TF for lesions smaller than 1 cm (p < 0.001), but this was not the case for larger lesions (p = 0.053). The signal-to-noise ratio in the liver was similar between platforms (p = 0.52). Also, shorter acquisition times were possible using the Discovery MI, with preserved signal-to-noise ratio in the liver. CONCLUSIONS: Image quality was better with Discovery MI compared to conventional Gemini TF. Although no gold standard was available, the results indicate that the new PET-CT generation will provide potentially better diagnostic performance.

Qualitative interpretation of PET scans using a Likert scale to assess neck node response to radiotherapy in head and neck cancer.

PURPOSE: The aim of this study was to determine whether PET scans after radiotherapy (RT), visually interpreted as equivocal regarding metabolic neck node response can be used to accurately categorize patients as responders or nonresponders using a Likert scale and/or maximum standardized uptake value (SUVmax). Other aims were to determine the performance of different methods for assessing post-RT PET scans (visual inspection, a Likert scale and SUVmax) and to establish whether any method is superior in predicting regional control (RC) and overall survival (OS). METHODS: In 105 patients with neck node-positive head and neck cancer, the neck node response was evaluated by FDG PET/CT 6 weeks after RT. The scans were clinically assessed by visual inspection and, for the purposes of this analysis, re-evaluated using the Deauville criteria, a five-point Likert scale previously used in lymphoma studies. In addition, SUVmax was determined. RESULTS: All assessment methods were able to significantly predict RC but not OS. The methods were also able to significantly predict remission of tumour after completion of RT. Of the 105 PET scans, 19 were judged as equivocal on visual inspection. The Likert scale was preferable to SUVmax for grouping patients as responders or nonresponders. CONCLUSION: All methods (visual inspection, SUVmax and the Likert scale) identified responders and nonresponders and predicted RC. A Likert scale is a promising tool to reduce to a minimum the problem of PET scans judged as equivocal. Consensus regarding qualitative assessment would facilitate PET reporting in clinical practice.

PET/CT imaging 2 h after injection of [18F]PSMA-1007 can lead to higher staging of prostate cancer than imaging after 1 h.

BACKGROUND: [18F]PSMA-1007 is a prostate specific membrane antigen (PSMA) ligand for positron emission tomography (PET) imaging of prostate cancer. Current guidelines recommend imaging 90-120 min after injection but strong data about optimal timing is lacking. Our aim was to study whether imaging after 1 h and 2 h leads to a different number of detected lesions, with a specific focus on lesions that might lead to a change in treatment. METHODS: 195 patients underwent PET with computed tomography imaging 1 and 2 h after injection of [18F]PSMA-1007. Three readers assessed the status of the prostate or prostate bed and suspected metastases. We analyzed the location and number of found metastases to determine N- and M-stage of patients. We also analyzed standardized uptake values (SUV) in lesions and in normal tissue. RESULTS: Significantly more pelvic lymph nodes and bone metastases were found and higher N- and M-stages were seen after 2 h. In twelve patients (6.1%) two or three readers agreed on a higher N- or M-stage after 2 h. Conversely, in two patients (1.0%), two readers agreed on a higher stage at 1 h. SUVs in suspected malignant lesions and in normal tissues were higher at 2 h, but lower in the blood pool and urinary bladder. CONCLUSIONS: Imaging at 2 h after injection of [18F]PSMA-1007 leads to more suspected metastases found than after 1 h, with higher staging in some patients and possible effect on patient treatment.

Freely Available, Fully Automated AI-Based Analysis of Primary Tumour and Metastases of Prostate Cancer in Whole-Body [18F]-PSMA-1007 PET-CT.

Here, we aimed to develop and validate a fully automated artificial intelligence (AI)-based method for the detection and quantification of suspected prostate tumour/local recurrence, lymph node metastases, and bone metastases from [18F]PSMA-1007 positron emission tomography-computed tomography (PET-CT) images. Images from 660 patients were included. Segmentations by one expert reader were ground truth. A convolutional neural network (CNN) was developed and trained on a training set, and the performance was tested on a separate test set of 120 patients. The AI method was compared with manual segmentations performed by several nuclear medicine physicians. Assessment of tumour burden (total lesion volume (TLV) and total lesion uptake (TLU)) was performed. The sensitivity of the AI method was, on average, 79% for detecting prostate tumour/recurrence, 79% for lymph node metastases, and 62% for bone metastases. On average, nuclear medicine physicians' corresponding sensitivities were 78%, 78%, and 59%, respectively. The correlations of TLV and TLU between AI and nuclear medicine physicians were all statistically significant and ranged from R = 0.53 to R = 0.83. In conclusion, the development of an AI-based method for prostate cancer detection with sensitivity on par with nuclear medicine physicians was possible. The developed AI tool is freely available for researchers.

A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy - The PROPER 1 trial.

Background and purpose: The treatment of biochemical recurrence (BCR) after prostatectomy is challenging as the site of the recurrence is often undetectable. Our aim was to test a personalised treatment concept for BCR based on PSA kinetics during salvage radiotherapy (SRT) combined with prostate-specific membrane antigen positron emission tomography (PSMA-PET). Materials and methods: This phase II trial included 100 patients with BCR. PSMA-PET was performed at baseline. PSA was measured weekly during SRT. Initially, 70 Gy in 35 fractions was prescribed to the prostate bed. Radiotherapy was adapted after 50 Gy. Non-responders (PSA still ≥ 0.15 ng/mL) received sequential lymph node irradiation with a boost to PSMA-PET positive lesions, while responders (PSA < 0.15 ng/mL) continued SRT as planned. PET-findings were only taken into consideration for treatment planning in case of PSA non-response after 50 Gy. Results: Data from 97 patients were eligible for analysis. Thirty-four patients were classified as responders and 63 as non-responders. PSMA-PET was positive in 3 patients (9%) in the responder group and in 22 (35%) in the non-responder group (p = 0.007). The three-year failure-free survival was 94% for responders and 68% for non-responders (median follow-up 38 months). There were no significant differences in physician-reported urinary and bowel toxicity. Patient-reported diarrhoea at end of SRT was more common among non-responders. Conclusion: This new personalised treatment concept with intensified SRT based on PSA response demonstrated a high tumour control rate in both responders and non-responders. These results suggest a clinically significant effect with moderate side effects in a patient group with otherwise poor prognosis. PSMA-PET added limited value. The treatment approach is now being evaluated in a phase III trial.Clinical trial registration numbers: NCT02699424&ISRCTN45905321.

11C-Metomidate PET/CT Detected Multiple Ectopic Adrenal Rest Tumors in a Woman With Congenital Adrenal Hyperplasia.

CONTEXT: Women with congenital adrenal hyperplasia (CAH) may present with androgen excess that is difficult to control with conventional suppressive doses of glucocorticoids. Clinical management is challenging, and the woman is at great risk of developing steroid-induced complications. PATIENTS AND METHODS: A 32-year-old woman with salt-wasting CAH due to 21-hydroxylase deficiency underwent right-sided adrenalectomy because of a large myelolipoma. Over the years, androgens became increasingly difficult to suppress on prednisolone 5 + 0 + 2.5 mg daily, and at age 39 years the left adrenal with an enlarging myelolipoma was removed. A month later serum testosterone levels had increased from 4.1 preoperatively to 18.3 nmol/L (reference 0.2-1.8 nmol/L), and adrenocorticotropin levels from 32 to 283 pmol/L (reference < 14 pmol/L). No adrenal parenchyma was visualized on computed tomography (CT). In the further search for the source of the markedly elevated testosterone, positron emission tomography (PET) was performed with 2 different tracers, 18fluorodeoxyglucose (18FDG) reflecting glucose metabolism and 11C-metomidate, an inhibitor of 11-ß-hydroxylase targeting adrenocortical tissue. RESULTS: 18FDG-PET/CT with cosyntropin stimulation showed ovarian/paraovarian hypermetabolism, suggestive of adrenal rest tumors. Further characterization with 11C-metomidate PET/CT showed uptakes localized to the ovaries/adnexa, behind the spleen, and between the right crus diaphragmaticus and inferior vena cava. CONCLUSION: Adrenal rest tumors can give rise to high androgen levels in spite of suppressive supraphysiological glucocorticoid doses. This case illustrates, for the first time, the value of 11C-metomidate PET as a sensitive method in documenting adrenal rest tumors, currently considered rare in women with CAH.

Adaptive sequential plan-on-plan optimization during prostate-specific antigen response guided radiotherapy of recurrent prostate cancer.

BACKGROUND: Treatment adaptation based on tumour biomarker response during radiotherapy of prostate cancer, could be used for both escalation and de-escalation of radiation doses and volumes. To execute an adaptation involving extension of treatment volumes during radiation can however be restricted by the doses already delivered. The aim of this work was to develop a treatment planning method that addresses this challenge. MATERIAL AND METHODS: A volumetric-modulated-arc-therapy (VMAT) planning method with sequential plan-on-plan optimization was developed for a prospective phase II trial including 100 patients on salvage radiotherapy (SRT) for prostate cancer recurrence. A treatment adaptation was performed after five weeks of SRT based on prostate-specific antigen response during this phase of the treatment. This involved extension of treatment volumes for non-responders (n = 64) to include pelvic lymph nodes and boost to 68Gallium-Prostate-Specific-Membrane-Antigen-Positron-Emission-Tomography positive lesions. This method was evolved by introducing an EQD2 (equivalent dose in 2.0 Gy fractions) correction of the base plan for improved dose coverage. RESULTS: All dose-volume criteria for target coverage were met for the non-responders when based on physical dose. An EQD2 correction of the base plan for non-responders, implemented for the final 29 patients, led to a statistically significant improvement in dose coverage as compared to the 35 patients treated without EQD2 correction. CONCLUSIONS: This is to our knowledge the only study presented on biomarker-guided sequential VMAT radiotherapy using a plan-on-plan technique in the pelvis. By using a biologically adapted technique an improved target coverage was achieved without compromising doses to organs at risk.

Optimization of [18F]PSMA-1007 PET-CT using regularized reconstruction in patients with prostate cancer.

BACKGROUND: Prostate-specific membrane antigen (PSMA) radiotracers such as [18F]PSMA-1007 used with positron emission tomography-computed tomography (PET-CT) is promising for initial staging and detection of recurrent disease in prostate cancer patients. The block-sequential regularization expectation maximization algorithm (BSREM) is a new PET reconstruction algorithm, which provides higher image contrast while also reducing noise. The aim of the present study was to evaluate the influence of different acquisition times and different noise-suppressing factors in BSREM (ß values) in [18F]PSMA-1007 PET-CT regarding quantitative data as well as a visual image quality assessment. We included 35 patients referred for clinical [18F]PSMA-1007 PET-CT. Four megabecquerels per kilogramme were administered and imaging was performed after 120 min. Eighty-four image series per patient were created with combinations of acquisition times of 1-4 min/bed position and ß values of 300-1400. The noise level in normal tissue and the contrast-to-noise ratio (CNR) of pathological uptakes versus the local background were calculated. Image quality was assessed by experienced nuclear medicine physicians. RESULTS: The noise level in the liver, spleen, and muscle was higher for low ß values and low acquisition times (written as activity time products (ATs = administered activity × acquisition time)) and was minimized at maximum AT (16 MBq/kg min) and maximum ß (1400). There was only a small decrease above AT 10. The median CNR increased slowly with AT from approximately 6 to 12 and was substantially lower at AT 4 and higher at AT 14-16. At AT 4-6, many images were regarded as being of unacceptable quality. For AT 8, ß values of 700-900 were considered of acceptable quality. CONCLUSIONS: An AT of 8 (for example as in our study, 4 MB/kg with an acquisition time of 2 min) with a ß value of 700 performs well regarding noise level, CNR, and visual image quality assessment.

Comparison between silicon photomultiplier-based and conventional PET/CT in patients with suspected lung cancer-a pilot study.

BACKGROUND: Lung cancer is one of the most common cancers in the world. Early detection and correct staging are fundamental for treatment and prognosis. Positron emission tomography with computed tomography (PET/CT) is recommended clinically. Silicon (Si) photomultiplier (PM)-based PET technology and new reconstruction algorithms are hoped to increase the detection of small lesions and enable earlier detection of pathologies including metastatic spread. The aim of this study was to compare the diagnostic performance of a SiPM-based PET/CT (including a new block-sequential regularization expectation maximization (BSREM) reconstruction algorithm) with a conventional PM-based PET/CT including a conventional ordered subset expectation maximization (OSEM) reconstruction algorithm. The focus was patients admitted for 18F-fluorodeoxyglucose (FDG) PET/CT for initial diagnosis and staging of suspected lung cancer. Patients were scanned on both a SiPM-based PET/CT (Discovery MI; GE Healthcare, Milwaukee, MI, USA) and a PM-based PET/CT (Discovery 690; GE Healthcare, Milwaukee, MI, USA). Standardized uptake values (SUV) and image interpretation were compared between the two systems. Image interpretations were further compared with histopathology when available. RESULTS: Seventeen patients referred for suspected lung cancer were included in our single injection, dual imaging study. No statically significant differences in SUVmax of suspected malignant primary tumours were found between the two PET/CT systems. SUVmax in suspected malignant intrathoracic lymph nodes was 10% higher on the SiPM-based system (p = 0.026). Good consistency (14/17 cases) between the PET/CT systems were found when comparing simplified TNM staging. The available histology results did not find any obvious differences between the systems. CONCLUSION: In a clinical setting, the new SiPM-based PET/CT system with a new BSREM reconstruction algorithm provided a higher SUVmax for suspected lymph node metastases compared to the PM-based system. However, no improvement in lung cancer detection was seen.

Impact of acquisition time and penalizing factor in a block-sequential regularized expectation maximization reconstruction algorithm on a Si-photomultiplier-based PET-CT system for 18F-FDG.

BACKGROUND: Block-sequential regularized expectation maximization (BSREM), commercially Q. Clear (GE Healthcare, Milwaukee, WI, USA), is a reconstruction algorithm that allows for a fully convergent iterative reconstruction leading to higher image contrast compared to conventional reconstruction algorithms, while also limiting noise. The noise penalization factor ß controls the trade-off between noise level and resolution and can be adjusted by the user. The aim was to evaluate the influence of different ß values for different activity time products (ATs = administered activity × acquisition time) in whole-body 18F-fluorodeoxyglucose (FDG) positron emission tomography with computed tomography (PET-CT) regarding quantitative data, interpretation, and quality assessment of the images. Twenty-five patients with known or suspected malignancies, referred for clinical 18F-FDG PET-CT examinations acquired on a silicon photomultiplier PET-CT scanner, were included. The data were reconstructed using BSREM with ß values of 100-700 and ATs of 4-16 MBq/kg × min/bed (acquisition times of 1, 1.5, 2, 3, and 4 min/bed). Noise level, lesion SUVmax, and lesion SUVpeak were calculated. Image quality and lesion detectability were assessed by four nuclear medicine physicians for acquisition times of 1.0 and 1.5 min/bed position. RESULTS: The noise level decreased with increasing ß values and ATs. Lesion SUVmax varied considerably between different ß values and ATs, whereas SUVpeak was more stable. For an AT of 6 (in our case 1.5 min/bed), the best image quality was obtained with a ß of 600 and the best lesion detectability with a ß of 500. AT of 4 generated poor-quality images and false positive uptakes due to noise. CONCLUSIONS: For oncologic whole-body 18F-FDG examinations on a SiPM-based PET-CT, we propose using an AT of 6 (i.e., 4 MBq/kg and 1.5 min/bed) reconstructed with BSREM using a ß value of 500-600 in order to ensure image quality and lesion detection rate as well as a high patient throughput. We do not recommend using AT < 6 since the risk of false positive uptakes due to noise increases.

Multiple pressure-volume loops recorded with sinusoidal low flow in a porcine acute respiratory distress syndrome model.

OBJECTIVES: To develop a method for automatic recording of multiple dynamic elastic pressure-volume (P(el)/V) loops. To analyse the relationship between multiple dynamic P(el)/V loops and static P(el)/V loops in a porcine model of acute lung injury/acute respiratory distress syndrome (ALI/ARDS). To test the hypothesis that increasing lung collapse and re-expansion with decreasing positive end expiratory pressure (PEEP) can be characterized by hysteresis of the P(el)/V loops. MATERIAL AND INTERVENTIONS: In eight anaesthetized and paralysed pigs, ALI/ARDS was induced by inhalation of dioctyl sodium sulfosuccinate and large tidal volume ventilation. MEASUREMENTS AND RESULTS: The physiological and histopathological findings indicated a status mimicking an early stage of ALI/ARDS. Automatically, a series of dynamic P(el)/V loops from different PEEP levels were recorded with the sinusoidal flow modulation method using a computer-controlled ventilator. During expiration, resistance increased more than twofold. For each step of lower starting pressure, the inspiratory limb was displaced towards lower volume indicating derecruitment. Recruitment occurred between 20 and 40 cm H(2)O. The expiratory curves, all starting from 50 cm H(2)O, overlapped. Hysteresis increased significantly in loops recorded from lower PEEP levels. Viscoelasticity explained differences between static and dynamic P(el)/V loops. CONCLUSIONS: Automated multiple P(el)/V loop determination is feasible and provides comprehensive information on lung derecruitment and recruitment. It requires determination of volume dependence of expiratory resistance. An expiratory curve serves as a reference to inspiratory curves and provides information about hysteresis.

Lung ventilation/perfusion SPECT in the artificially embolized pig.

UNLABELLED: Planar lung scintigraphy is a standard method used for the diagnosis of lung embolism, but it is hampered by the high incidence of nondiagnostic tests. Ventilation/perfusion SPECT may possibly improve this situation. The objective of this study was to compare planar lung scintigraphy with ventilation/perfusion SPECT using pigs with artificially engendered lung emboli labeled with (201)Tl. METHODS: Sixteen anesthetized pigs were each injected with zero to 4 latex emboli. Cylindric emboli were used in the first 7 pigs and flat 3-tailed emboli were used in the remaining 9 pigs. The pigs spontaneously inhaled 30 MBq (99m)Tc-diethylenetriaminepentaacetic acid aerosol for ventilation scintigraphy. Planar scintigraphy and SPECT were performed using a double-head gamma camera in (99m)Tc and (201)Tl windows. Immediately thereafter, 100 MBq (99m)Tc-labeled macroaggregated albumin were injected intravenously followed by SPECT and, finally, planar scintigraphy. The ventilation background was subtracted from the perfusion tomograms for calculation of a normalized ventilation/perfusion (V/P) quotient image set. RESULTS: The cylindric emboli caused artifacts in the ventilation images; therefore, these were excluded from the final analysis. However, for the planar perfusion images of these pigs, sensitivity and specificity were 71% and 91%, respectively, whereas SPECT yielded 100% for both. For the 3-tailed emboli and ventilation/perfusion images, the sensitivity and specificity were 64% and 79%, respectively, for the planar modality, whereas SPECT yielded values of 91% and 87%, respectively. CONCLUSION: V/P SPECT may improve the diagnostic power of lung scintigraphy.

Dynamic elastic pressure-volume loops in healthy pigs recorded with inspiratory and expiratory sinusoidal flow modulation. Relationship to static pressure-volume loops.

OBJECTIVE: The objective was to analyse relationships between inspiratory and expiratory static and dynamic elastic pressure-volume (P(el)/V) curves in healthy pigs. DESIGN: The modulated low flow method was developed to allow studies also of the expiratory P(el)/V curves. Static P(el)/V (P(el,st)/V) and dynamic P(el)/V (P(el,dyn)/V) loops were studied in healthy pigs. SETTING: Animal research laboratory in a university hospital. MATERIAL: Ten healthy anaesthetised and paralysed pigs. INTERVENTIONS AND MEASUREMENTS: A computer controlled a Servo Ventilator 900C with respect to respiratory rate, inspiratory flow and expiratory pressure to achieve a sinusoidal modulation of inspiration and expiration for determination of P(el,dyn)/V loops from zero end-expiratory pressure (ZEEP) and from a positive end-expiratory pressure (PEEP) of 6 cmH(2)O to 20, 35 and 50 cmH(2)O. The same system was used for studies of P(el,st)/V loops with the flow-interruption method from ZEEP and PEEP to 35 cmH(2)O. Recordings were analysed with an iterative technique. RESULTS: The feasibility of automated determination of P(el,dyn)/V loops was demonstrated. Differences between P(el,dyn)/V and P(el,st)/V loops were explained by viscoelastic behaviour. P(el,st)/V loops recorded from PEEP to 35 cmH(2)O showed no significant hysteresis, indicating a non-significant surface tension hysteresis. P(el,dyn)/V loops from PEEP and both P(el,st)/V and P(el,dyn)/V loops from ZEEP to 35 cmH(2)O showed hysteresis. This indicates that lung collapse/re-expansion caused P(el)/V loop hysteresis which, in P(el,dyn)/V loops, was augmented by viscoelastic behaviour. CONCLUSIONS: Viscoelasticity influences P(el,dyn)/V curves. Hysteresis caused by surface tension merits re-evaluation. Lung collapse and re-expansion may be indicated by hysteresis of P(el)/V loops.

Measurement and mathematical modelling of elastic and resistive lung mechanical properties studied at sinusoidal expiratory flow.

Elastic pressure/volume (P(el) /V) and elastic pressure/resistance (P(el) /R) diagrams reflect parenchymal and bronchial properties, respectively. The objective was to develop a method for determination and mathematical characterization of P(el) /V and P(el) /R relationships, simultaneously studied at sinusoidal flow-modulated vital capacity expirations in a body plethysmograph. Analysis was carried out by iterative parameter estimation based on a composite mathematical model describing a three-segment P(el) /V curve and a hyperbolic P(el) /R curve. The hypothesis was tested that the sigmoid P(el) /V curve is non-symmetric. Thirty healthy subjects were studied. The hypothesis of a non-symmetric P(el) /V curve was verified. Its upper volume asymptote was nearly equal to total lung capacity (TLC), indicating lung stiffness increasing at high lung volume as the main factor limiting TLC at health. The asymptotic minimal resistance of the hyperbolic P(el) /R relationship reflected lung size. A detailed description of both P(el) /V and P(el) /R relationships was simultaneously derived from sinusoidal flow-modulated vital capacity expirations. The nature of the P(el) /V curve merits the use of a non-symmetric P(el) /V model.

Outpatient tinzaparin therapy in pulmonary embolism quantified with ventilation/perfusion scintigraphy.

BACKGROUND: Out-of-hospital treatment of patients with deep-vein thrombosis (DVT) is routine in many countries regardless of frequent concomitant asymptomatic pulmonary embolism (PE) in this group. However, patients with symptoms and verified PE are still regularly treated in hospital. The objectives were to test a model for outpatient tinzaparin therapy and to evaluate its safety and efficacy in patients with symptomatic, small or medium-sized PE using quantitative ventilation/perfusion scintigraphy (qV/P SCINT) for patient selection and follow up. MATERIAL/METHODS: This prospective study included 102 patients treated with tinzaparin and warfarin for 5 days at a patient hotel. PE was quantified scintigraphically as loss of perfusion with preserved ventilation at segmental or subsegmental levels (mismatch). Points were attributed to segments of reduced ventilation (RoVent) and perfusion (RoPer). A holistic principle of interpretation was applied. Patients were excluded if they had >14 RoPer points (7 segments) or >7 RoVent points. Clinical follow-up and scintigraphy were repeated at discharge in 100 patients and after 13 months on average. RESULTS: Embolism diminished by 44% after 5 days and demanding symptoms declined. There was no thromboembolic mortality in the trial. At late follow-up, PE had not recurred in patients with resolution after 5 days. In those with insufficient early response, persistent perfusion defects were usually observed. CONCLUSIONS: The results indicate the safety and efficacy of outpatient treatment of PE according to our model and merit larger, multicenter, controlled studies.