Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Inflammation

Uterine Cervical Neoplasms

Syndrome

Colorectal Neoplasms

Prostatic Neoplasms

Ovarian Neoplasms

Colonic Neoplasms

Rectal Neoplasms

Urinary Bladder Neoplasms

Anus Neoplasms

Flatulence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Ovarian Cancer

Anal Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Herbal and Botanical

Psyllium

Calcium polycarbophil

The participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. Altogether the fifteen capsules contains 5.5 g dietary fiber in psyllium husk.

The participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. The capsules contain placebo (maltodextrin) and have a similar look as in the experimental arm.

The participants are invited to eat 15 capsules per day. The capsules either contain dietary fiber from psyllium husk or placebo.

Capsules containing either dietary fiber or placebo

Rebecca Ahlin, M.Sc.

Daniel Munkberg, Dietician

Johanna Svensson, MD

Gunnar N Steineck, MD, PhD

Maria Hedelin, PhD

Cecilia Bull, PhD

The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. All participants are advised to consume at least 16 g of dietary fiber/day via food. In addition, participants are invited to take capsules that together contain either 5.5 g of dietary fiber from psyllium husk or placebo.

The overall working hypothesis is that intake of dietary fiber during radiotherapy can mitigate or hinder end states or the triggering of long-lasting pathophysiological processes that decreases intestinal health in the cancer survivor. If correct, there is a dose-effect relationship to be documented. Moreover, if correct, different kinds of dietary fibers may have different effects. Mechanisms for the mitigatory effects may be that dietary fiber helps to preserve the two protective mucus layers and hinder gut-wall starvation. Lack of protection, as well as gut-wall starvation, may decrease the gut walls' integrity. That, in turn, may enhance bacterial migration from the lumen into the gut wall, causing unnecessary inflammation. This inflammation may, in turn, lead to a number of different pathophysiological processes, including a chronic self-propagating low-grade inflammation. Clinical experience suggests the intake of dietary fiber during radiotherapy may increase acute intestinal side effects. Our own data suggest a modest, if any, increase by dietary fiber.

Through recipes of tasty meals by price-winning chefs and general advice, the investigators guide the participant to try to consume at least 16 g of dietary fiber per day via food. The guidance takes place through telephone calls, calls via video link, and text on a website or paper material. The participant gets access to a mobile application that measures the daily intake of dietary fiber. Dietary fiber is ingested in 15 capsules with psyllium husk which contains a total of 5.5 g of dietary fiber. The investigators ask the participant to take the capsules two weeks before radiotherapy, during radiotherapy, and to stop four weeks after the end of radiotherapy. Placebo capsules (maltodextrin) are taken in the same way. To document the frequency of acute side effects, and what symptoms they cause, the participant is asked to report patient-reported outcomes once a week via a mobile application. They are also welcome to report side effects to the study office.

One month after the end of radiotherapy, the degree of inflammation is measured via markers in the blood and feces. One year after the end of radiotherapy, intestinal health is measured via patient-reported outcomes. Blood and feces are collected and patient-reported outcomes are reported in questionnaires and a mobile application before, during, and at least one year after the end of radiotherapy. This data will be a source of in-depth analysis. Radiotherapy gives rise to increased intensity of five different syndromes, fecal-leakage syndrome, urgency syndrome, uncontrolled flatulence, excess mucus discharge, and anal blood discharge. Damage of nerves and small vessels, weakening the anal-sphincter function by muscle fibers turning into the connective tissue (fibrosis), may explain some of the intensity of the fecal-leakage syndrome. An ongoing self-propagating low-grade inflammation, small-vessel and nerve damage in the gut wall may be related to urgency. Reasonably the microbiome, and the communication between the microbiome and the gut wall, is related to uncontrolled flatulence and excess mucus discharge. It is not known to what extent telangiectasias on a fibrotic inner gut wall explains anal blood discharge. Ad hoc studies in FIDURA will explore suggested mechanisms.

An interim analysis will be performed for the primary outcome to identify if there is any effect of the intervention, to decide whether to continue or terminate the inclusion of patients in the study. The concentration of c-reactive protein will be analyzed for all included patients who have donated blood to date (May 2023). To ensure that the blinding is not revealed, all analyses (biochemical and statistical) will be made by external personnel not included in the research group. The capsules are marked with X and Y, and the code for which is intervention or placebo will not be revealed even for the external personnel performing the interim analysis.

Random allocation of patients and blinding of researchers, patients, healthcare professionals and outcome assessors.

Capsules that look alike, with dietary fiber or placebo.

Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial

Dietary Fiber During Radiotherapy and Intestinal Inflammation - a Placebo-controlled Randomized Trial (FIDURA)

As soon as we we have started publishing data we will successively make our data available to other researchers.

Metrics obtained from freshly frozen defecated feces. The investigators plan to use next-generation sequencing.

Concentration of c-reactive protein in plasma or serum

Patient-reported outcomes through a validated questionnaire. The metric for the intensity of the urgency syndrome weighs the frequency of several symptoms by factor loadings, as described in PubMed ID 28158314. Examples of the previous usage can be seen in PubMed ID 28366105 and PubMed ID 30601820.

Deviation from the recommended intake of 15 capsules per day

Concentration of selected markers in blood and feces. The selection of cytokines and chemokines for this outcome is work in progress 26 august 2020 and will be be given as updated information later on. In feces we will primarily use elastase and calprotectin.

Patient-reported outcomes through a validated questionnaire. The metric for the intensity of the syndromes weighs the frequency of several symptoms by factor loadings, as described in PubMed ID 28158314. Examples of the previous usage can be seen in PubMed ID 28366105 and PubMed ID 30601820.

Distress from gastrointestinal symptoms as reported through a mobile phone application (ePROMS). Primarily we ask for defecation frequency, stool consistency (Bristol Scale), and frequency of abdominal pain. The participants may also report other side-effects, either by the mobile phone application, video link, or telephone with the study secretariat.

The Swedish Research Council

VGregion

Sjöbergstiftelsen

Sahlgrenska University Hospital, Sweden

Senior Professor

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Breast Neoplasms

Melanoma

Neoplasm Metastasis

Lymphoma

Lymphoma, Follicular

Hodgkin Disease

Melanoma, Cutaneous Malignant

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Breast Diseases

Lymphosarcoma

Follicular Lymphoma

Hodgkin Lymphoma

Small Intestine Cancer

Neuroendocrine Tumor

Neuroepithelioma

Fluorodeoxyglucose F18

A total of 85 18F-FDG-PET adult studies were gathered over a 3-month period and retrospectively evaluated.

To verify the application of methodology in clinical routine, we conducted a second phase of the study prospectively in 250 subjects (phase 2) using inclusion and exclusion criteria of the retrospective study (phase 1).

Will be observed all patients who perform PET / CT examinations, independent of clinical indication, in nuclear medicine at Hospital Sao Rafael. Those who show interest in participating in the study, will be provided free and informed consent form (ICF) for your appreciation. This evaluation will serve for analysis and quantification of PET-CT images.

Image quantify

Milena BP Soares, PhD

Vinicius O Menezes, BSc

Marcos AD Machado, BSc

Cleiton C Queiroz, BSc

Mauro Namias, MSc

Identify the best combination of predictive variables that influence ionizing radiation dose and improved image quality through analysis and quantification of PET-CT images in simulators and patients.

Defining PET / CT Protocols With Optimized F18-FDG (Fluorodeoxyglucose) Dose, Focusing on Reduced Radiation Dose and Improved Image Quality

The image noise will be measured by VOI (Volume Of Interest) in the images. The units of measure will be kilograms (kg) for body weight, and percentage for the variation coefficient.

The dose-regimen will be calculated based on radiation dose and body surface. The image noise will be measured by VOI (Volume Of Interest) in the images. The units of measure will be MegaBecquerel per kilogram (MBq/kg) for dose-regimen, and percentage for the variation coefficient.

Images will be acquired every 30 seconds until a maximum of 360 seconds. The image noise will be measured by VOI (Volume Of Interest) in the images. The units of measure will be seconds for the acquisition time, and percentage for the variation coefficient.

Hospital Sao Rafael

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neoplastic Processes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Pancreatic Cancer

Antineoplastic Agents

Adagrasib

Cola

Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination

Expansion cohorts in NSCLC and CRC patients to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with BI 1701963

MRTX849

BI 1701963

This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.

This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.

Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)

A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation

Number of participants with treatment related adverse events

Number of patients with dose limiting toxicity

Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Boehringer Ingelheim

Mirati Therapeutics Inc.

Crohn Disease

Inflammatory Bowel Diseases

Gastroenteritis

Cohort 1: Predetermined points measurement: 10 subjects with measurement of bowel gas at 8 predetermined time points during right laparoscopic colectomy as follow:

1. Initiation of surgery/laparoscopy start Insufflation
2. Abdominal exploration
3. Completion of colon mobilization
4. Colon transection
5. At Colotomy
6. At Enterotomy
7. Anastomosis completion
8. End of surgery- after re-insufflation before closure

Cohort 2: Continuous monitoring: 10 subjects with continuous monitoring of bowel gases through the surgery. The level of H2 and CH4 gases will be noted at the 8 predetermined time points during the continuous monitoring as well.

The Perf-AlertTM prototype consists of a 15" x 13" x 7" unit containing gas sensors and valves, a small box containing a one-way, ultra-low pressure pump, user controls (buttons), and software algorithms, which control the operation of the device. It is used in conjunction with a single-use, disposable kit of sterile tubing and filters used for sample collection. The sensing unit will be connected via a sterile tube/filter set to any trocar port in use during the procedure. At specific time points during surgery, a one-way valve will be opened, and the unit's pump turned on and withdrawing a small amount of gas from the abdominal cavity. The system is configured that sample collection, transport, analysis, and feedback occur in a single step such that sample collection and sensor feedback occur in real-time. A standard laptop running an analytical software program is connected to the unit to record and log sensor readings.

Obtaining bowel gas samples

Rohit Rasane

Ananya Sen

Alessio Pigazzi, MD,PhD

Undetected bowel perforation is a rare but dangerous complication of laparoscopic surgery. If the injury is not detected and treated at the time of the surgical procedure, the patient can suffer severe complications, including septic shock and eventually death. The investigator's goal is to test a novel device that can detect bowel gas leakage from perforation and alert the surgeon during the operation by evaluating the gases present in the insufflated abdomen during surgery. This study will determine the ability of the device to be attached to a standard trocar during the operation and periodically draw small samples or aliquots of gas from the abdomen to evaluate the gas and accurately detect gaseous content from the bowel. Before the device can be used to detect bowel perforations, the investigators must first ensure that it can accurately detect bowel gas in an insufflated abdomen.

The goal of this study is to test a novel device that can detect bowel gas leakage from perforation and alert the surgeon during the operation by evaluating the gases present in the insufflated abdomen during surgery. During laparoscopic surgery, CO2 is inserted into the abdominal cavity in order to perform the operation. This is a dynamic process as insufflation is constant during the entire procedure to maintain constant pressure and compensate for any small leaks due to the insertion and retrieval of instruments.

This study will determine the ability of a novel device to be attached to a standard trocar during the operation and periodically draw a small amount of gas from the abdomen to evaluate the gas and accurately detect gaseous content from the bowel. Before the device can be used to detect bowel perforations, first the investigators must ensure that it can accurately detect bowel gas in an insufflated abdomen.

The Investigational device, Perf-AlertTM, consists of a 15" x 13" x 7" unit containing gas sensors and valves, a small box containing a one way, ultra-low pressure pump, user controls (buttons), and software algorithms, which control the operation of the device ( Image1). It is used in conjunction with a single-use, disposable kit consisting of sterile tubing and filters used for sample collection and transport (Image 2). The sensing unit will be connected via a sterile tube/filter set to any trocar port in use during the procedure. At specific time points during the procedure, a one-way valve will be opened and the unit's pump turned on pulling small aliquots of gas from the abdominal cavity to the sensing unit. The system's architecture is configured such that sample collection, transport, analysis, and feedback occur in a single step such that sample collection and sensor feedback occur in real-time. A standard laptop running an analytical software program is connected to the unit to record and log sensor readings. No changes to the device are anticipated during the course of the study.

Prospective pilot, single-center, single-arm, open-label, phase 1 investigator-initiated study to determine device ability to detect bowel gas during laparoscopic right colectomy with intracorporeal anastomosis using Perf-AlertTM gas detection system on 20 subjects into 2 Cohorts.

Cohort 1: 10 subjects with measurement of bowel gas at 8 predetermined time points during right laparoscopic colectomy as follow:

1. Initiation of surgery/laparoscopy start Insufflation
2. Abdominal exploration
3. Completion of colon mobilization
4. Colon transection
5. At Colotomy
6. At Enterotomy
7. Anastomosis completion
8. End of surgery- after re-insufflation before closure

Cohort 2: 10 subjects with continuous monitoring of bowel gases through the surgery. The level of H2 and CH4 gases will be noted at the 8 predetermined time points during the continuous monitoring as well.

Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis

Methane (CH4) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points

Hydrogen (H2) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points

The response time of the Perf-AlertTM device measured in seconds from obtaining the sample (from opening the valve to obtain sample) to first detecting a gas presence at the device electronic sensors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial	NCT04534075	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Gynecologic Can...	Capsules contai...	18 Years - 80 Years	Sahlgrenska University Hospital, Sweden
Defining PET / CT Protocols With Optimized F18-FDG (Fluorodeoxyglucose) Dose, Focusing on Reduced Radiation Dose and Improved Image Quality	NCT02378337	Malignant Neopl... Hodgkin Disease Non-Hodgkin Lym... Malignant Neopl... Malignant Neopl... Secondary Neopl... Malignant Melan... Malignant Neopl...	Image quantify	18 Years -	Hospital Sao Rafael
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)	NCT04975256	Advanced Cancer Metastatic Canc... Malignant Neopl... Malignant Neopl... Malignant Neopl...	MRTX849 BI 1701963	18 Years -	Mirati Therapeutics Inc.
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial	NCT04534075	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Gynecologic Can...	Capsules contai...	18 Years - 80 Years	Sahlgrenska University Hospital, Sweden
Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis	NCT04964297	Crohn's Disease... Malignant Neopl...	Obtaining bowel...	18 Years -	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for malignant neoplasm of colon