Cone-beam CT: An Additional Imaging Tool in the Interventional Treatment and Management of Low-flow Vascular Malformations

PurposeTo evaluate the impact of cone-beam computed tomography (CT) during sclerotherapy of low-flow vascular malformations.Materials and MethodsEighty-seven cone-beam CT examinations were acquired during 81 sclerotherapy treatments of low-flow malformations in 48 patients: 81 were performed to evaluate sclerosing agent diffusion and six were performed to evaluate needle or catheter positioning before injection of therapeutic agent. Image quality was rated by two observers. Clinical impact of cone-beam CT in the assessment of therapeutic agent diffusion, needle or catheter positioning, subsequent treatment planning, and complication detection was evaluated. The κ-statistic was used to assess interobserver reliability and proportions, with associated 95% confidence intervals (CIs).ResultsAll cone-beam CT images were successfully acquired. Image quality was rated as excellent or good for the majority of studies, with substantial interobserver reliability (κ = 0.648). Cone-beam CT studies improved assessment of therapeutic agent diffusion in 83% of cases (67 of 81; 95% CI, 75%–91%) for observer 1, who had access to ultrasound, fluoroscopic, and digital subtraction angiographic (DSA) imaging, and in 95% of cases (77 of 81; 95% CI, 90%–100%) for observer 2, who had access to only stored fluoroscopic spot radiographs and DSA images. Cone-beam CT impacted planning of the next treatment session in 49% of cases (40 of 81; 95% CI, 38%–60%). In 7% of cases (six of 81; 95% CI, 1%–13%), complications such as migration of therapeutic agent or compression of upper airways were detected that were not seen with other imaging.ConclusionsCone-beam CT can be a useful adjunctive imaging tool, providing information to help decision-making during percutaneous sclerotherapy and ongoing management of low-flow vascular malformations.     

Magnetic resonance imaging of the axial skeleton enables objective measurement of tumor response on prostate cancer bone metastases

BACKGROUND: There is currently no technique to image quantitatively bone metastases. Here, we assessed the value of MRI of the axial skeleton (AS-MRI) as a single step technique to quantify bone metastases and measure tumor response. METHODS: AS-MRI was performed in 38 patients before receiving chemotherapy for metastatic HRPCa, in addition to PSA, computed tomography of the thorax, abdomen, and pelvis [CT-TAP]; and Tc-99m bone scintigraphy. A second AS-MRI was performed in 20 patients who completed 6 months of chemotherapy. Evaluation of tumor response was performed using RECIST. RESULTS: Only 11 patients (29%) had RECIST measurable metastases in soft-tissues or lymph nodes on baseline CT-TAP. AS-MRI identified a diffuse infiltration of the bone marrow in 8 patients and focal measurable metastatic lesions in 25 patients (65%), therefore, doubling the proportion of patients with measurable lesions. Transposing RECIST on AS-MRI in 20 patients who completed 6 months of treatment, allows the accurate estimation of complete response (n = 2), partial response (n = 2), stable disease (n = 5), or tumor progression (n = 11), as it is done using CT-TAP in soft tissue solid metastases. CONCLUSIONS: MRI of axial skeleton enables precise measurement and follow-up of bone metastases as it is for other soft-tissue metastasis.     

TuBaFrost 3: regulatory and ethical issues on the exchange of residual tissue for research across Europe

The regulatory regimes for research with residual tissue and accompanying data differ widely between countries in the European Union (EU): from specific consent to opt-out or even no consent at all. This could greatly hamper research where the exchange of tissue and accompanying data has become the gold standard, like in TubaFrost. Instead of adhering to international guidelines, which have a democratic deficit, or an attempt for a new set of possible harmonising rules, TubaFrost chose to create a coordinating rule: if tissue may legitimately be used for a certain kind of research in the country where it was taken and under whose jurisdiction the patient falls, it may also be used for such research in the country where it is sent to in the context of a scientific program even if in that other country other regulations would apply for research with residual tissue taken from patients under their jurisdiction. This coordinating rule has a sound basis in EU law in general and will solve the problems related to diverging national regulatory regimes in the case of cross national research with residual tissue.     

RECIST vs. WHO: prospective comparison of response criteria in an EORTC phase II clinical trial investigating ET-743 in advanced soft tissue sarcoma

The present study was set up just after the publication of the response evaluation criteria in solid tumors (RECIST) as a prospective validation exercise in soft tissue sarcoma. Forty-nine patients were entered into a phase II clinical trial aiming at determining the activity and safety of ET-743 (Ecteinascidin) in second line advanced soft tissue sarcoma. Response to treatment and progression were monitored following the WHO criteria and RECIST. Discordances between WHO and RECIST criteria for the best response were reported for two cases: one no-change (WHO) reported as partial response (RECIST) and one progression (WHO) reported as no-change (RECIST). In terms of date of progression, 3 patients progressed on WHO criteria while they were still stable with RECIST. Overall the results of the study would not have changed if RECIST had been used instead of WHO criteria. In conclusion, response criteria as defined by RECIST are adequate to measure response and progression in non-GIST soft tissue sarcoma and can be used instead of the modified WHO criteria.