Quantifying inter-individual anatomical variability in the subcortex using 7 T structural MRI.

Functional magnetic resonance imaging (MRI) data are usually registered into standard anatomical space. However, standard atlases, such as LPBA40, the Harvard-Oxford atlas, FreeSurfer, and the Jülich cytoarchitectonic maps all lack important detailed information about small subcortical structures like the substantia nigra and subthalamic nucleus. Here we introduce a new subcortical probabilistic atlas based on ultra-high resolution in-vivo anatomical imaging from 7 T MRI. The atlas includes six important but elusive subcortical nuclei: the striatum, the globus pallidus internal and external segment (GPi/e), the subthalamic nucleus, the substantia nigra, and the red nucleus. With a sample of 30 young subjects and carefully cross-validated delineation protocols, our atlas is able to capture the anatomical variability within healthy populations for each of the included structures at an unprecedented level of detail. All the generated probabilistic atlases are registered to MNI standard space and are publicly available.

Tactile feedback exceeds visual feedback to display tissue slippage in a laparoscopic grasper.

Virtual reality can help to learn basic laparoscopic tasks. However, no haptic feedback, which alerts for tissue slippage, is provided by most simulators, although, it might be of influence for the decrease of errors. This study explored whether visual or tactile feedback can be used to alert the surgeon of tissue slippage. Twenty-four participants performed a laparoscopic grasping task and where provided with either visual or tactile feedback about tissue slippage. The reaction time with the visual feedback was compared to the reaction time with tactile feedback signal. The results showed that when tissue slippage is simulated, tactile feedback shows significant faster reaction times (269ms) than visual feedback signals (398ms).

Haptics in minimally invasive surgery--a review.

This article gives an overview of research performed in the field of haptic information feedback during minimally invasive surgery (MIS). Literature has been consulted from 1985 to present. The studies show that currently, haptic information feedback is rare, but promising, in MIS. Surgeons benefit from additional feedback about force information. When it comes to grasping forces and perceiving slip, little is known about the advantages additional haptic information can give to prevent tissue trauma during manipulation. Improvement of haptic perception through augmented haptic information feedback in MIS might be promising.

Shoe design for prevention of injuries in sport climbing.

Foot injuries and deformations are more frequent at higher levels of sport climbing. These are accepted as unavoidable because it is assumed that, for optimal performance, a prerequisite is the wearing of a shoe, which is too tight and has an unnatural shape. Based on a biomechanical analysis, we came up with a different approach to shoe design. By using regional thinning of the sole, easy flexion and extension of the toes is made possible. The form of the shoe conforms to the natural form of the foot, the shoe closure provides a close fit for feet with width differences of up to 20 mm and a shoe-sizing system was developed. After testing prototypes, we conclude that the new shoe design can contribute to the prevention of foot injuries and deformations in sport climbing.

Phase I study of high-dose epirubicin in platinum-pretreated patients with ovarian carcinoma.

BACKGROUND: In vitro data demonstrated a dose-response relationship for doxorubicin in ovarian cancer (OC) cell lines. However, this dose-response question for doxorubicin was never carefully addressed in OC patients. These data and the more favorable toxicity profile of the anthracycline analogue epirubicin prompted us to study high-dose epirubicin (HDE) in relapsed OC patients. PATIENTS AND METHODS: This phase I study included 19 OC patients with measurable or evaluable disease and no more than one prior (cisplatin-containing) chemotherapy regimen. Dose escalation was not allowed in individual patients. Epirubicin was administered by rapid intravenous infusion (<5 min) once every 3 weeks and studied at the following dose levels: 120, 135, 150, 180 and 200 mg/m2 (at least 3 patients per dose level). None of the patients received hematopoietic growth factors. We defined the maximum tolerated dose (MTD) as the dose at which we observed WHO grade 4 hematologic toxicity in >/=50% and/or WHO grade 3 nonhematologic toxicity in >/=30% of the patients. RESULTS: The MTD was 200 mg/m2, with DLT being both hematologic (leukopenia and/or thrombocytopenia) and nonhematologic (mucositis). Objective responses were observed in 6 patients (response rate 32%), 3 of them occurring in 10 patients with primary platinum resistance. CONCLUSIONS: HDE is tolerable and has activity in second-line after cisplatin-based chemotherapy in OC patients. The recommended dose for phase II trials in such patients is 150 mg/m2, with escalation to 180 mg/m2 if toxicity permits.

High-dose epirubicin in platinum-pretreated patients with ovarian carcinoma: the EORTC-GCCG experience.

BACKGROUND: A dose-response relationship for doxorubicin in ovarian cancer (OC) cell lines has been demonstrated in vitro. However, this has never been carefully addressed in the clinic. These data and the more favourable toxicity profile of the anthracycline analogue epirubicin were reasons to study high-dose epirubicin (HDE) in OC patients who relapsed on/after platinum-based chemotherapy. This was done both in a phase I/II feasibility study (n = 27; HDE dose 120-200 mg/m2 q3 weeks) and a still ongoing straightforward phase II study (n = 91; HDE dose 150-180 mg/m2 q 3 weeks). RESULTS: Responses were observed at all dose levels. Overall 24 of the 118 patients responded (20%), which is much higher than reported with lower doses (7% with doses of 60-110 mg/m2). The most important side effects were myelosuppression, alopecia, nausea and vomiting and mucositis. CONCLUSION: HDE is tolerable and has activity in second-line after platinum-based chemotherapy in OC patients.

Multicenter phase II study of spiroplatin.

Spiroplatin was investigated in a multicenter phase II study, during which the drug was given over 4 h. 64 Patients with nine different solid tumors received 141 cycles of spiroplatin at a dose of 30 mg/m2 every 3 weeks. Most important side effects included nausea, vomiting, myelosuppression, and renal toxicity. Four of 11 evaluable patients with prior cisplatin developed increases in serum creatinine (3 transient, 1 died of renal failure). Of 51 patients without prior cisplatin 2 had a transient increase in serum creatinine levels, and 2 showed persistent changes, in 1 of them leading to hemodialysis. Pre- and posthydration did not reduce drug-induced nephrotoxicity. Only 3 patients showed a response; 1 with renal cell carcinoma, 1 with ovarian carcinoma, and 1 with malignant melanoma. Based on the absence of striking antitumor activity and on the presence of severe unpredictable renal toxicity, the study was stopped prematurely.

A prospective study of untunnelled subclavian vein catheters in hematooncology patients.

In patients with hematological malignancies, we prospectively evaluated the use of untunnelled subclavian vein catheters placed either for short term chemotherapy (48 episodes) or for long-term intensive supportive care during pancytopenia (152 episodes). The 200 catheters were placed in 88 different patients. There were 2 placement failures and 2 cases of minor pneumothorax. In 4 episodes ecchymoses and in 1 uncontrollable bleeding from the exit site occurred. The mean time to removal was 25.6 days (range 0-149). There was 1 exit site infection and 26 periods of septicemia, of which 8 were considered catheter associated. All infections responded to appropriate treatment. Irreversible obstruction occurred in 4 and dislodgement in another 4 episodes out of a total number of 11 failures. Patient acceptance was high although repeated placements were frequently undertaken for successive periods of treatment and supportive care. With meticulous sterile techniques of placement and catheter care it seems that untunnelled subclavian vein catheters are reliable and safe in hematooncology.

A pilot study on the quality of data management in a cancer clinical trial.

Twelve institutional data managers were asked to independently code the data from a patient chart of one patient in an ovarian cancer trial. They abstracted data from the medical record and filled out three types of trial forms (on-study, chemotherapy, and summary forms). The analysis of the processed data revealed that the median rate of errors was 13% for the 12 data managers. The error rate differed among the types of trial forms. The factors causing these errors were mistakes in interpretation, documentation, and coding. The level of experience of the data managers proved to be an important factor. It became clear that the documentation in the medical record was inadequate. We conclude that data managers as well as physicians involved in cancer clinical trials need specific training and that the quality of data management in cancer clinical trials is an important issue for further investigation.