Radioimmunoscintigraphy of recurrent, metastatic, or occult colorectal cancer with technetium Tc 99m 88BV59H21-2V67-66 (HumaSPECT®-Tc), a totally human monoclonal antibody

PURPOSE: The study contained herein was undertaken to evaluate the accuracy of radiolabeled human monoclonal antibody, 88BV59H21-2V67-66 (88BV59 or HumaSPECT®-Tc), in predicting disease resectability in presurgical subjects with recurrent, metastatic, or occult colorectal carcinoma. METHODS: A total of 219 patients with disease visualized on computed tomographic scan (recurrent or metastatic disease) or with negative or equivocal computed tomographic scan and rising carcinoembryonic antigen serum levels (occult group) received technetium Tc 99m-labeled 88BV59 intravenously. Planar and single photon emission computed tomographic images were obtained 14 to 20 hours postinfusion, before surgery. The ability of computed tomographic and HumaSPECT®-Tc imaging to define the extent of disease and to predict resectability was evaluated based on surgical and histopathologic results. RESULTS: In patients with recurrent or metastatic disease (170 evaluable patients), the accuracy of predicting non-resectability of disease was significantly greater (P<0.001) for HumaSPECT®-Tc than for computed tomography (60vs. 29 percent). Computed tomography understaged 41 percent of patients believed to have resectable disease compared with 27 percent for HumaSPECT®-Tc (P<0.001). In occult disease patients (29 computed tomographic and 28 HumaSPECT®-Tc evaluable patients), the overall accuracy of predicting resectability/nonresectability was 68 percent for HumaSPECT®-Tc compared with 24 percent for computed tomography. Administration of HumaSPECT®-Tc had no effect on monoclonal antibody-basedin vitro diagnostic assays. Only a single patient demonstrated an anti-antibody response (90 ng/ml) at nine weeks postinfusion. CONCLUSION: HumaSPECT®-Tc was more accurate than computed tomography in determining disease resectability in patients with metastatic, recurrent, or occult cancer. The addition of HumaSPECT®-Tc imaging can play a significant role in patient management decisions.Supported in part by a grant from INTRACEL Corporation (formerly PerImmune, Inc.), Rockville, Maryland.     

The MACTAR Patient Preference Disability Questionnaire--an individualized functional priority approach for assessing improvement in physical disability in clinical trials in rheumatoid arthritis

A new approach to assessing disability in arthritis that quantifies the functional priorities of the patient is described. Comparison against global improvement suggests that this instrument has the potential to detect small clinically important changes in function.     

Therapeutic Interleukin-6 Trans-signaling Inhibition by Olamkicept (sgp130Fc) in Patients With Active Inflammatory Bowel Disease

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Effects of Poly(2′-O-Methyladenylic Acid) on Susceptibility and Autogenous Immunity to RNA Tumor Virus Oncogenesis In Vivo

Poly(2'-O-methyladenylic acid) [poly(Am)] inhibited tumor development and death induced by the Moloney sarcoma virus-leukemia virus complex in newborn mice. The compound was effective at 10 mug per mouse when given at least 1 hr before inoculation of virus, but the greatest inhibition was seen in mice treated at least 4 hr before infection. Poly(2'-O-methyluridylic acid) and poly(vinyladenine) also inhibited sarcoma development and death but were less effective than poly(Am). Poly(Am) also enhanced the antibody response of newborn mice to endogenous leukemia virus envelope antigens, which we refer to as autogenous immunity. The results of these preliminary studies suggest that poly(Am) altered the oncogenic potential of the Moloney sarcoma-leukemia virus complex in vivo, and the effect appears to be mediated through an enhancement of the immune response of the treated animals.     

Fecal immunochemical test in cancer screening – colonoscopy outcome in FIT positives and negatives

Objectives: Fecal immunochemical test (FIT) is used in colorectal cancer (CRC) screening, but evaluations of multiple sample strategies in colonoscopy screening cohorts are rare. The aim of this study was to assess accuracy of FIT for advanced neoplasia (AN) with two fecal samples in a colonoscopy screening cohort.

Materials and methods: The study comprised 1155 participants of the colonoscopy arm in SCREESCO (Screening of Swedish Colons, NCT02078804), a randomized controlled study on CRC screening of 60-year-olds from the Swedish average-risk population. Participants provided two FIT samples prior to colonoscopy. First sample, mean of two, and any of the two samples above cut off level were assessed. Colonoscopy findings (CRC, advanced adenoma (AA), AN (CRC?+?AA) and adenoma characteristics) were evaluated in uni- and multivariable analysis in relation to FIT positivity (at ≥10?µg hemoglobin (Hb)/g).

Results: Of 1155 invited, 806 (416 women, 390 men) participated. CRC, AA and non-AA were found in one (0.1%), 80 (9.9%) and 145 (18%), respectively. Sensitivity and specificity for AN were 20%/93%, 25%/92% and 26%/89% for first, mean of two and any of the two samples respectively at cut off level 10?µg/g, corresponding to 60 (74%)–65 (80%) participants with missed AN. The difference in sensitivity between screening strategies was non-significant. The specificity for first sample was significantly higher than for any of the two samples at cut off 10?µg/g (p?=?.02) and 20?µg/g (p?=?.04). FIT positivity in participants with adenoma was associated with pedunculated shape (p?=?.007) and high-risk dysplasia (p?=?.009).

Conclusions: In an average-risk colonoscopy screening cohort of 60-year-olds, sensitivity for AN was modest and did not increase when using two samples instead of one. FIT predominantly detected adenomas with pedunculated shape and high-risk dysplasia, and participants with flat or broad based adenomas may thus be missed in screening.     

Evaluation of tracheal imaging by optical coherence tomography

BACKGROUND: Optical coherence tomography (OCT) is a new technology capable of generating high resolution cross-sectional images of complex tissue in real time. Analogous to ultrasound, OCT measures backscattered light intensity using coherence interferometery to construct topographical images of complex tissue. Since OCT uses infrared light rather than acoustic waves, its spatial resolution is exceptionally high (2-10 microm). Recent advances in data acquisition, analysis, and processing enable real-time imaging, and make OCT a potentially valuable tool for pulmonary airway diagnostic applications, including assisting directed airway biopsies. OBJECTIVE: This study evaluates feasibility of OCT for delineating proximal airway microstructures in various animal as well as human tracheas. METHODS: Excised trachea samples from New Zealand white rabbits, Duroc pigs, and human trachea were imaged using a compact, 1,300-nm broad-band superluminescent-diode-based prototype fiber OCT device we constructed. The resulting structural OCT images were compared to conventional hematoxilin and eosin (HE) stained histological sections from the same samples. RESULTS: OCT was able to delineate microstructures such as the epithelium, mucosa, cartilage, and glands in all samples. Conclusion: These findings suggest that integration of OCT with flexible fiberoptic bronchoscopy could enhance pulmonary diagnostic medicine and detection of pathologic tissue changes in various respiratory diseases.     

Life-threatening postoperative hemorrhage from hepatic artery pseudoaneurysm successfully treated by transcatheter embolization in a 5-year-old

Upper gastrointestinal bleeding caused by a pseudoaneurysm after hepatobiliary operation is well described in adults. This can be successfully treated with transcatheter embolization under angiographic guidance. We report a case of massive upper gastrointestinal bleeding in a 5-year-old boy secondary to a pseudoaneurysm of the right hepatic artery after choledochal cyst excision. A coil embolization successfully treated this life-threatening event and spared the child, the morbidity of a challenging gastrointestinal and vascular reconstruction. Use of percutaneous interventional technique to treat this rare complication of choledochal cyst excision has not been previously described in the pediatric surgical literature. Transcatheter embolization of a pseudoaneurysm may be a safe and less morbid treatment alternative for this surgical complication even in the pediatric population.     

Observational clinical human reliability analysis (OCHRA) for competency assessment in laparoscopic colorectal surgery at the specialist level

Background  

There are no valid and reliable tools to assess competency in advanced laparoscopic surgery at a specialist level. The observational clinical human reliability analysis (OCHRA) may have the required characteristics of such a tool. The aim of this study was to evaluate construct and concurrent validity of OCHRA for competency assessment at a specialist level.