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Sentinel lymph node excision with or without preoperative hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) in melanoma: study protocol for a multicentric randomized controlled trial.

ABSTRACT: BACKGROUND:Melanoma has become a growing interdisciplinary problem in public health worldwide. According to the World Health Organization, the incidence of melanoma is increasing faster than any other cancer in the world. Because melanoma metastasizes early into the regional lymph nodes, sentinel lymph node excision (SLNE) is included in the current American Joint Committee of Cancer guidelines. However SLNE of melanoma has a high false-negative rate of up to 44%. METHODS:The gold standard for detection and extirpation of the sentinel lymph node is preoperative lymphoscintigraphy. SPECT/CT provides complementary information: the advantages include accurate anatomical localization, identification of false positives, reduction in the number of false negatives, and alteration of the surgical approach. Therefore, sentinel lymph node-SPECT/CT provides valuable information before sentinel lymph node excision and advocates its use in melanoma. We present a multicenter, unblinded superiority randomized controlled trial to compare SPECT/CT-aided SLNE versus standard SLNE in melanoma patients. DISCUSSION:The primary efficacy endpoint is distant metastasis-free survival. Secondary endpoints comprise overall survival, disease-free survival, rate of local relapses within the follow-up period (false-negative rate of sentinel lymph node), number of positive sentinel lymph nodes (sensitivity, false-positive rate), complication rate, quality of life, quality-adjusted life years, inpatient days, and overall costs during hospital stays. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03683550 . Registered on 20 September 2018.

SUBMITTER: Stoffels I

PROVIDER: S-EPMC6360709 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Project description:Functional imaging modalities enable practitioners to identify functional lung regions. This analysis evaluated the feasibility of nuclear medicine imaging to avoid doses to the functional lung in radiotherapy (RT) planning for patients with lung cancer. This systematic review and meta-analysis was carried out according to PRISMA-P guidelines. A search of EMBASE and PubMed for studies published throughout the last 20 years was performed using the following search criteria: (a) 'lung cancer' or 'lung malignancy' and (b) 'radiotherapy' or 'radiation therapy' or 'RT planning' and (c) 'SPECT' or 'single positron emission computed tomography' or 'functional image.' The analyzed planning parameters were the volumes of the normal lung that have received ≥ 10 Gy and ≥ 20 Gy of radiation (V10 and V20, respectively) and the mean lung dose (MLD). We compared the planning parameters obtained from anatomical RT planning and functional RT planning using perfusion or ventilation imaging ('V10, V20 or MLD' in anatomical plan vs. 'fV10, fV20 or fMLD' in functional plan). A total of 309 patients with 344 RT plan sets from 15 publications (11 perfusion SPECT, 2 ventilation SPECT, and 1 SPECT and 1 PET with both perfusion and ventilation) were included in the meta-analysis. The standard mean differences in planning parameters in functional plans using nuclear imaging were significantly reduced compared to those of anatomical plans (P < 0.01 for all): - 0.42 (95% confidence interval (CI) - 0.78 to - 0.07) for 'V10 vs. fV10', - 0.41 (95% CI - 0.64 to - 0.17) for 'V20 vs. fV20', and - 0.24 (95% CI - 0.45 to - 0.03) for 'MLD vs. fMLD'. In subgroup analysis, the functional plan using perfusion was significantly lower than the anatomical plan in all planning parameters, but there was no significant difference for ventilation. RT planning with nuclear functional lung imaging has potential to reduce radiation-induced lung injury. Perfusion imaging seems to be more promising than ventilation imaging for all planning parameters. There were not enough studies using ventilation imaging to determine what the effect is on the lung plan parameters.

Project description:We present the attenuated spline reconstruction technique (aSRT) which provides an innovative algorithm for single photon emission computed tomography (SPECT) image reconstruction. aSRT is based on an analytic formula of the inverse attenuated Radon transform. It involves the computation of the Hilbert transforms of the linear attenuation function and of two sinusoidal functions of the so-called attenuated sinogram These computations are achieved by employing the attenuation information provided by computed tomography (CT) scans and by utilizing custom-made cubic spline interpolation. The purpose of this work is: (i) to present the mathematics of aSRT, (ii) to reconstruct simulated and real SPECT/CT data using aSRT and (iii) to evaluate aSRT by comparing it to filtered backprojection (FBP) and to ordered subsets expectation minimization (OSEM) reconstruction algorithms. Simulation studies were performed by using an image quality phantom and an appropriate attenuation map. Reconstructed images were generated for 45, 90 and 180 views over 360 degrees with 20 realizations and involved Poisson noise of three different levels (NL), namely 100% (NL1), 50% (NL2) and 10% (NL3) of the total counts, respectively. Moreover, real attenuated SPECT sinograms were reconstructed from a real study of a Jaszczak phantom, as well as from a real clinical myocardial SPECT/CT study. Comparisons between aSRT, FBP and OSEM reconstructions were performed using contrast, bias and image roughness. The results suggest that aSRT can efficiently produce accurate attenuation-corrected reconstructions for simulated and real phantoms, as well as for clinical data. In particular, in the case of the clinical myocardial study, aSRT produced reconstructions with higher cold contrast than both FBP and OSEM. aSRT, by incorporating the attenuation correction within itself, may provide an improved alternative to FBP. This is particularly promising for 'cold' regions as those occurring in myocardial ischaemia.

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Sentinel lymph node excision with or without preoperative hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) in melanoma: study protocol for a multicentric randomized controlled trial.

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