Clinical trialObsUnknown
Neoadjuvant Treatment of Resectable or Locally Advanced Borderline Pancreatic Adenocarcinoma: Reproducibility of Tumor Measurement in CT VS MRI
Neoadjuvant Treatment of Resectable or Locally Advanced Borderline Pancreatic Adenocarcinoma: Reproducibility of Tumor Measurement in CT Versus MRI
- Outcome
- Outcome unknown
- Phase
- Obs
- Status
- Unknown
- Study type
- Observational
- Start
- 18 July 2022
- Expected end
- 31 December 2023
- Enrollment
- 48 participants
- Sites
- 1
- Primary outcomes
- Inter-observer reproducibility
- Sponsor
- Other
- Results posted
- No
- Last update
- 7 March 2023
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
Despite important therapeutic advances, pancreatic adenocarcinoma remains one of the cancers with a high mortality rate (4th leading cause of cancer death in the US in 2021), poor prognosis (5-year overall survival rate of 10%) and increasing incidence. Patients are often metastatic from the start or at an advanced stage at diagnosis, making curative treatment difficult to envisage. Although the gold standard of treatment for resecable pancreatic adenocarcinoma is initial surgery followed by adjuvant chemotherapy, considerable interest has emerged in a treatment strategy involving neoadjuvant therapy in patients at high risk for positive resection margins (R1) on initial imaging workup. The assessment of response to neoadjuvant therapy is complex, especially for the evaluation of vascular invasion with a high risk of overestimating residual invasion after neoadjuvant therapy. Accurate assessment of tumor size before and after neoadjuvant treatment is therefore crucial to identify good responders (according to RECIST 1.1 criteria) and thus improve the selection of patients who can benefit from curative surgery with healthy resection margins (R0). In clinical practice, tumor size assessment is performed by injected computed tomography (CT). The latter has certain advantages in terms of technical reproducibility, but has a number of limitations. Indeed, the delineation of the tumor mass in CT seems to be subject to a significant inter-observer variability. The same is true for vascular invasion. CT also seems to underestimate the size of the tumor compared to the anatomopathological examination of the surgical specimen. On the other hand, Magnetic Resonance Imaging (MRI) has been shown to be superior to CT in tumor detectability and diagnosis of malignancy in the presence of an indeterminate pancreatic mass. It has also been shown that tumor size, whether measured in diameter or volume, is frequently underestimated on CT compared to multiparametric MRI or pathological examination of the resection specimen. In the latest recommendations of the National Comprehensive Cancer Network (NCCN), MRI is indicated at diagnosis in non-metastatic patients with indeterminate liver lesions on CT, or as a second-line alternative to CT for re-evaluation after neo-adjuvant therapy in patients with resectable or borderline resectable disease according to the NCCN classification. However, MRI is increasingly performed routinely in some centers, both at diagnosis and at re-evaluation after neo-adjuvant therapy. The question of which imaging modality between CT and multiparametric MRI is the most reproducible in terms of tumor size measurement becomes important, especially in the evaluation of the response to neoadjuvant therapy. A few studies have investigated the interobserver variability of tumor size measurement in CT versus MRI in the context of radiotherapy management for the delineation of an irradiation field, but to date investigators have not found any study evaluating the interobserver variability of tumor size measurement using RECIST criteria before and after neoadjuvant treatment for pancreatic adenocarcinoma.
Papers 6
- BackgroundImaging Assessment of Pancreatic Cancer Resectability After Neoadjuvant Therapy: AJR Expert Panel Narrative Review. DOI 10.2214/ajr.21.26931↗
- BackgroundPancreatic Adenocarcinoma, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. DOI 10.6004/jnccn.2021.0017↗
- BackgroundNeoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma. DOI 10.1159/000493466↗
- BackgroundTrends in pancreatic adenocarcinoma incidence and mortality in the United States in the last four decades; a SEER-based… DOI 10.1186/s12885-018-4610-4↗
- BackgroundPancreatic adenocarcinoma: MRI conspicuity and pathologic correlations. DOI 10.1007/s00261-014-0196-8↗
- BackgroundVariability of target and normal structure delineation using multimodality imaging for radiation therapy of pancreatic … DOI 10.1016/j.ijrobp.2014.02.035↗