Prospective comparison of radiologic, thoracoscopic, and pathologic staging in patients with early non-small cell lung cancer.

BACKGROUND: More accurate staging at the time of initial presentation could improve design of clinical trials and avoid inappropriate surgical decisions in individual patients. Preresection staging of patients with non-small cell lung cancer (NSCLC) is not straightforward, especially in patients with negative mediastinal nodes. The purpose of this study was to compare the results of radiologic, thoracoscopic, and pathologic staging in patients with NSCLC and negative mediastinoscopy. METHODS: All patients with NSCLC underwent computed tomographic (CT) scanning before surgical staging with mediastinoscopy. Patients with negative mediastinoscopy then underwent thoracoscopic staging with examination of pleural surfaces, and identification of T (visceral and parietal pleural invasion, sampling of pleural fluid, and pleural lavage) and N (intraparenchymal and inferior mediastinal nodal sampling, if possible) stage descriptors before resection. RESULTS: Thoracoscopy was more accurate than CT scanning in the staging of 50 patients with early lung cancer (stages IA, IB, IIA, and IIB), especially as regards T stage. Further, thoracoscopic examination ruled out malignant pleural effusions in 7 (14%) patients with radiologically obvious effusions, and identified radiologically silent malignant pleural effusions in 3 (6%) patients. Chest wall invasion was accurately identified at thoracoscopy in most patients. Finally, 3 patients with T1 lower lobe lesions and negative mediastinoscopy were found to have involvement of inferior mediastinal nodes (level 8 or 9) at thoracoscopy. However, thoracoscopy did not allow sampling of aortopulmonary window nodes in some patients with bulky left upper lobe lesions. CONCLUSIONS: Errors in thoracoscopic staging resulted in no inappropriate operations. However, errors in CT staging would have resulted in operations unlikely to help the patients, or would have inappropriately excluded patients from surgery. Thoracoscopic staging was more accurate than CT staging in this cohort of patients with NSCLC and negative mediastinoscopy.

A multisite phase III study of the safety and efficacy of a new manganese chloride-based gastrointestinal contrast agent for MRI of the abdomen and pelvis.

The purpose of this study was to evaluate the safety and efficacy of a manganese chloride-based oral magnetic resonance (MR) contrast agent during a Phase III multisite clinical trial. Two hundred seventeen patients were enrolled who were already scheduled for MRI of the abdomen and/or pelvis. In this group of patients, it was postulated that the use of an oral agent would better allow discrimination of pathology from bowel. Patients with known gastrointestinal pathology including peptic ulcer disease, inflammatory bowel disease, obstruction, or perforation were excluded to minimize confounding variables that could affect the safety assessment. Of these 217 patients, 18 received up to 900 mL of placebo, and 199 patients were given up to 900 mL of a manganese chloride-based oral contrast agent, LumenHance (Bracco Diagnostics, Inc.). Safety was determined by comparing pre- and post-dose physical examinations, vital signs, and laboratory examinations and by documenting adverse events. Efficacy was assessed by unblinded site investigators and two blinded reviewers who compared pre- and post-dose T1- and T2-weighted MRI scans of the abdomen and/or pelvis. In 111 (57%) of the 195 cases evaluated for efficacy by site investigators (unblinded readers), MRI after LumenHance provided additional diagnostic information. Increased information was found by two blinded readers in 52% and 51% of patients, respectively. In 44/195 cases (23%) unblinded readers felt the additional information would have changed patient diagnosis and in 50 patients (26%), it would have changed management and/or therapy. Potential changes in patient diagnosis or management/therapy were seen by the two blinded readers in 8-20% of patients. No clinically significant post-dose laboratory changes were seen. Forty-eight patients (24%) receiving LumenHance and four patients (22%) receiving placebo experienced one or more adverse events. Gastrointestinal tract side effects were most common, seen in 29 (15%) of LumenHance patients and in 3 (17%) of the placebo patients. LumenHance is a safe and efficacious oral gastrointestinal contrast agent for MRI of the abdomen and pelvis.

Staging recurrent metastatic colorectal carcinoma with PET.

UNLABELLED: Accurate detection of recurrent colorectal carcinoma remains a diagnostic challenge. The purposes of this study were to assess the accuracy of 18FDG-PET in patients with recurrent colorectal carcinoma in detecting liver metastases compared with computed tomography (CT) and CT portography, detecting extrahepatic metastases compared with CT and evaluating the impact on patient management. METHODS: Fifty-two patients previously treated for colorectal carcinoma presented on 61 occasions with suspected recurrence and underwent 18FDG-PET of the entire body. PET, CT and CT portography images were analyzed visually. The final diagnosis was obtained by pathology (n = 44) or clinical and radiological follow-up (n = 17). The impact on management was reviewed retrospectively. RESULTS: A total of 166 suspicious lesions were identified. Of the 127 intrahepatic lesions, 104 were malignant, and of the 39 extrahepatic lesions, 34 were malignant. Fluorine-18-fluorodeoxyglucose imaging was more accurate (92%) than CT and CT portography (78% and 80%, respectively) in detecting liver metastases and more accurate than CT for extrahepatic metastases (92% and 71%, respectively). Fluorine-18-fluorodeoxyglucose detected unsuspected metastases in 17 patients and altered surgical management in 28% of patients. CONCLUSION: These data identify that 18FDG-PET is the most accurate noninvasive method for staging patients with recurrent metastatic colorectal carcinoma and plays an important role in management decisions in this setting.