Cryotherapy

Researchers are evaluating the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy (TBLC) in people with progressive pulmonary fibrosis. The study aims to understand patient prognosis, health economic impacts, and how therapeutic strategies may change following TBLC. Participants diagnosed with progressive pulmonary fibrosis will be randomly divided into two groups to receive either transbronchial lung biopsy (TBLB) or TBLC. The study compares two procedures: transbronchial cryobiopsy, a newer technique used to diagnose various diffuse lung diseases, and transbronchial lung biopsy, a more commonly used and relatively safe diagnostic method. These procedures will be performed to assess their diagnostic value and safety in this patient population. Participants are assigned randomly to one of these two biopsy methods. During the study, participants will be monitored for diagnostic performance one month after biopsy. Safety assessments will be conducted at seven days and one month after the procedure. Researchers will collect data on lung function, imaging, and clinical status to evaluate outcomes. The study will continue until the end of 2026, with detailed follow-up to measure the impact of each biopsy technique on diagnosis and patient care.

Researchers are investigating the levels of the CENP-V protein in human oocytes to understand its role as a potential diagnostic marker for oocyte damage related to aging and the freezing process called vitrification. The study focuses on women with advanced maternal age (AMA) and compares them to younger control patients. The research addresses a concern that aging and freezing may reduce oocyte quality, affecting fertility and survival rates after thawing. The study involves analyzing immature oocytes that would otherwise be discarded from patients with AMA and control patients, as well as oocytes subjected to vitrification and thawing. Patients are divided into groups by age and fertility status, including those undergoing ovarian stimulation and oocyte collection. Only immature or donated mature oocytes not used for treatment are included in the analysis. Participants will have their oocytes collected and assessed within two days from enrollment to retrieval. The study measures the levels and distribution of CENP-V in these oocytes and tracks the survival rate of oocyte cohorts after thawing. This observational study does not involve treatment but focuses on laboratory analysis to identify markers of oocyte damage, which could inform future fertility evaluations.

Researchers are exploring the safety, feasibility, and initial effectiveness of combining controlled cold exposure with standard PD-1/PD-L1 immunotherapy for adults with solid tumors. This phase I, single-center, open-label study plans to include 24 participants receiving standard immunotherapy either alone or in combination, according to routine clinical practice. The study aims to assess how cold exposure influences immune responses, tumor biomarkers, and patient outcomes alongside immunotherapy. Participants will undergo a 2-day cold acclimation before starting the combined treatment, with temperature-controlled exposure at approximately 20B0C on Day -2 and 18B0C on Day -1. From Day 1, participants will be exposed daily to 18B0C for 12 hours over 7 consecutive days while receiving their immunotherapy. If well tolerated, this cold exposure may be repeated during subsequent treatment cycles. Standard immunotherapy regimens are selected based on tumor type and clinical guidelines. During the study, researchers will monitor safety, tolerability, and adherence to the cold exposure protocol, recording adverse events from the start of the intervention until 30 days after treatment ends. They will also evaluate tumor response through imaging performed every 6-12 weeks for up to a year, and assess survival outcomes for up to 36 months. Additional assessments include immune profiling, metabolomics, gut microbiota analysis, patient-reported outcomes, and biomarker studies on tumor tissue when available. The total duration of participant involvement depends on treatment response and follow-up schedules.

Researchers are evaluating the safety and effectiveness of combining cryoablation with Cadonilimab and Bevacizumab in treating people with hepatocellular carcinoma (HCC) that has spread to the lungs. HCC commonly metastasizes to the lungs, and while standard treatments focus on systemic therapy, this study explores adding cryoablation, which freezes tumors to kill cancer cells and stimulate immune responses, potentially enhancing treatment outcomes. Cadonilimab is a bispecific antibody targeting immune checkpoints, and Bevacizumab targets blood vessel growth factors that may suppress immune attack on tumors. Participants receive one of two treatment plans: either Bevacizumab plus Cadonilimab intravenously every three weeks, or cryoablation of lung metastases combined with the same drug regimen. Cryoablation aims to destroy lung tumors directly while the drugs work systemically to control cancer. The study is randomized and open-label, comparing these approaches to evaluate response rates and survival. During the study, participants will be monitored for tumor response, progression-free survival at six months, and overall survival at 12 months. Evaluations include imaging scans and clinical assessments to measure tumor size and treatment effects. The study duration extends up to January 2027, with regular visits for drug administration and follow-up to assess safety and efficacy outcomes.

Researchers are evaluating whether adding cryoablation to standard treatment with pembrolizumab, pemetrexed, and carboplatin improves one-year survival in patients with metastatic lung adenocarcinoma. This phase III, multicenter, open-label trial compares two groups: one receiving cryoablation plus standard drugs and the other receiving only the standard drug combination. The study investigates the possible survival benefit of combining these treatments for this advanced lung cancer. Participants are randomly assigned to one of two arms. The experimental arm receives cryoablation of one eligible visceral or bone metastasis (excluding liver and sclerotic bone lesions) alongside pembrolizumab and pemetrexed-carboplatin given according to approved dosing. Cryoablation is performed within 6 weeks after starting pembrolizumab. The control arm receives pembrolizumab, pemetrexed, and carboplatin without cryoablation. Treatment continues until disease progression, unacceptable toxicity, or other reasons for stopping. Participants undergo tumor assessments at baseline and every 9 weeks using RECIST v1.1 criteria. Blood samples and optional biopsies are collected at specified times including before treatment and at progression. Safety is monitored up to 90 days after the last immunotherapy or 12 months of treatment. Follow-up continues for up to 36 months after randomization to track tumor response, survival, and quality of life. The primary outcome is one-year overall survival rate, with multiple secondary outcomes including response rates and adverse events.

Researchers are investigating how caffeine affects the activity of brown adipose tissue (BAT) after exposure to mild cold. This study explores the role of adenosine A2A receptors in BAT activation, which is important for understanding potential treatments for metabolic diseases. The trial is a randomized, double-blind, placebo-controlled cross-over study involving healthy adults aged 18 to 40 years with moderate caffeine consumption. Participants will take a single oral dose of 200 mg caffeine or a placebo in two separate visits. After administration, they will undergo mild cold exposure using cooling sleeves around the waist that lower the skin temperature to 10°C or the lowest tolerable level without causing shivering. BAT activity will be measured using 18F-FDG PET/CT scans 30 minutes after injection of a radioactive tracer. Resting energy expenditure will also be assessed before and after treatment and cold exposure. During the study, participants will attend a screening visit and two main study visits in random order. Researchers will monitor energy expenditure, BAT activity, skin temperature, metabolite profiles, and other factors to evaluate the effects of caffeine versus placebo during cold exposure. The primary outcome is BAT uptake measured 30 minutes after intervention. The total participation period includes these visits and assessments, with safety and compliance closely followed.

Researchers are studying how different types of energy bars affect the body's use of fuel and aerobic performance during cold weather exposure. This randomized crossover study focuses on healthy adults aged 18 to 39 years who perform exercise in a cold environment (5°C) while wearing light clothing. The goal is to understand how bars higher in carbohydrate or higher in fat impact energy use and endurance during cold-weather military operations. Participants consume one of two types of isocaloric supplement bars (approximately 350 kcal): one higher in carbohydrates (50% carbs, 30% fat, 20% protein) or one higher in fat (30% carbs, 50% fat, 20% protein). The order of consumption is randomized and double-blinded. After consuming the bar, volunteers rest for 60 minutes in cold conditions, then perform 90 minutes of treadmill exercise carrying a load equal to 30% of their body weight. This is followed by a 2-mile time trial to assess endurance performance. There is a minimum washout period of six days between trials. During the study, researchers collect baseline data (height, weight, body composition, peak oxygen uptake) and monitor core and skin temperatures continuously. Indirect calorimetry is used to measure substrate oxidation during exercise, and serial blood samples assess circulating substrates and hormones. Exercise and diet are controlled, including a lead-in diet 24 hours before each trial. The study measures endurance performance over 30 minutes and substrate oxidation over 90 minutes. Participants are asked to abstain from alcohol, nicotine, and other supplements during the study periods.

Researchers are evaluating local cryotherapy as a treatment for recurrent head and neck cancers located in previously irradiated areas. This pilot study focuses on patients with unresectable locoregional recurrences, who have limited treatment options and poor survival rates. Traditional treatments like surgery and radiochemotherapy have limited success or cause significant toxicity, creating a need for alternative therapies with better safety and effectiveness profiles. Participants will receive local cryotherapy treatment, a minimally invasive technique that uses extreme cold to destroy cancer tissues. This procedure is being studied as a potential alternative to re-irradiation or surgery for tumors that cannot be removed. The study aims to assess the local tumor control rate at 12 months after treatment and monitor any complications or adverse events related to cryotherapy. During the study, patients will be closely monitored with assessments of tumor control at 6 and 12 months, evaluation of any side effects, and quality of life questionnaires at 1, 3, 6, and 12 months post-treatment. The research team will track patients’ overall health, kidney function, and other safety factors. Participation includes follow-up visits to measure outcomes and ensure patient well-being throughout the study period.

Researchers are studying the use of focal cryoballoon ablation to help relieve dysphagia (difficulty swallowing) in adults with incurable esophageal cancer. This pilot, multi-center, prospective study aims to assess the feasibility, safety, and effectiveness of this treatment, as well as its potential impact on the body's anti-tumor immune response. Current palliative options like stenting and radiotherapy have drawbacks, so this study explores cryotherapy as a possible alternative. Participants will receive cryoballoon ablation during an upper endoscopy, targeting visible tumor areas. Treatment involves two cycles of freezing lasting 12 seconds each. Patients can undergo between one to three treatment sessions spaced 1 to 3 weeks apart, depending on symptom severity. The study focuses on technical success, side effects, and symptom improvement following these procedures. Throughout the study, patients will be monitored for procedure safety and dysphagia improvement at 2 and 12 weeks after treatment. Researchers will also collect esophageal tumor biopsies and blood samples to evaluate immune responses. The total follow-up includes assessments of pain, other palliative effects, and longer-term safety, with the main outcomes measured shortly after the last treatment session.

This research aims to collect detailed information on the use of cryoablation procedures in children with soft tissue and bone lesions. Cryoablation is a minimally invasive technique that uses image guidance to insert specialized needles or probes into lesions, applying cycles of freezing and thawing to destroy tissue. While this method is well established for adults, especially in treating kidney tumors, its use in children is still new and not well documented. The study will audit the range of applications, success rates, safety, complications, and effectiveness of cryoablation in the pediatric population. The study involves children undergoing cryoablation therapy for benign soft tissue lesions. Cryoablation uses a mechanized unit connected to probes that freeze and thaw the targeted tissue via highly pressurized gases. This process causes tissue destruction both mechanically and through immune responses. The registry collects data from multiple centers in the UK and Europe, gathering standardized information about each procedure. Data will be anonymized and entered into a web-based system for analysis. The study is open and non-controlled, focusing on repeat treatments as determined by clinical decisions. Participants will be followed for up to five years to monitor outcomes such as changes in lesion size, symptom changes, procedure failures, and any complications within two years after treatment. The registry aims to provide evidence on safety, efficacy, and best practice for pediatric cryoablation. Data will be analyzed collectively while remaining owned by individual hospitals. This will help improve treatment guidance and support future clinical trials if needed. The total participation duration varies depending on treatment and follow-up schedules.