Drammen

Researchers are evaluating whether 18F-FDG PET/CT imaging can detect breast cancer metastases that conventional imaging methods like CT and bone scintigraphy might miss. This study focuses on women diagnosed with stage II/III or locoregional recurrent breast cancer to see if this advanced imaging method can provide more accurate disease staging, which may influence treatment decisions. The study also explores if specific imaging and molecular characteristics of the primary breast cancer relate to patient outcomes such as survival and disease progression. Participants with breast cancer will receive an 18F-FDG PET/CT scan in addition to the usual CT and bone scintigraphy scans. This imaging is done during the initial assessment to check for cancer spread beyond what conventional imaging finds. The trial collects detailed imaging data and biological samples to analyze tumor characteristics and their relationship to treatment results. During the study, researchers will monitor changes in disease staging and treatment plans based on the PET/CT scan findings over a five-year period. They will also measure overall survival and progression-free survival, comparing patients whose cancer stage changed after PET/CT to those whose stage remained the same. Imaging metrics from CT, MRI, and PET scans, as well as molecular tumor data, will be evaluated for links to patient outcomes. Participants will be closely followed and assessed through scans and clinical evaluations throughout the study duration.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are studying a new needle technique for Achilles tendon lengthening in children and adolescents aged 5 to 16 years who have conditions like spastic or non-spastic contracture and toe walking, causing shortening of the Achilles tendon and difficulty walking. This prospective study aims to evaluate the safety, effectiveness, and feasibility of this minimally invasive method as an alternative to traditional open or percutaneous surgery, which can cause scarring and complications. The study plans to include up to 50 young patients over two years and closely follow them for one year after surgery, with assessments by pediatric physiotherapists and ultrasound imaging to monitor tendon anatomy and healing. The needle technique involves making multiple tiny cuts in the Achilles tendon using a thin needle while stretching it, gradually weakening and lengthening the tendon without opening the skin or tendon sheath. The procedure is quick, taking about 3-4 minutes under local anesthesia, followed by applying a soft plaster boot cast that supports full weight-bearing immediately. The cast is worn for four weeks, then removed, after which gentle activity is allowed for four weeks before resuming unrestricted movement. Physical therapy may be provided as needed. Ultrasound exams are done before and one year after the procedure to check the tendon. Participants will be examined before surgery and at 4 weeks, 6 months, and one year afterward. Clinical tests include measuring ankle dorsiflexion, strength testing, and neurological assessments. Quality of life is measured using age-appropriate questionnaires completed by patients and parents. Data will be securely collected and analyzed to assess outcomes like ankle movement and patient satisfaction, ensuring thorough monitoring of safety and effectiveness throughout the study.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

This research aims to compare intismeran autogene combined with pembrolizumab versus placebo with pembrolizumab as an additional treatment after surgery for people with stage II, IIIA, or IIIB (with nodal involvement) non-small cell lung cancer (NSCLC) that has been fully removed with clear margins. The study is a phase 3 trial investigating whether the combination including intismeran autogene improves disease-free survival compared to the placebo combination. Participants will receive either intismeran autogene by intramuscular injection plus pembrolizumab by intravenous infusion or a placebo injection plus pembrolizumab. The treatments are given after surgery and standard platinum-based chemotherapy. No more than 24 weeks can pass from surgery to the first pembrolizumab dose. The study evaluates these treatments as adjuvant therapy to reduce cancer recurrence. During the trial, researchers will monitor participants for disease-free survival for up to approximately 78 months. Participants undergo regular assessments including medical evaluations to track cancer status and treatment effects. The study excludes those with prior neoadjuvant therapy, certain infections, or other cancer treatments that might interfere. Safety and long-term outcomes are carefully observed throughout the study period.

Researchers are evaluating the safety and effectiveness of combining vedolizumab with upadacitinib, called dual targeted therapy (DTT), compared to using vedolizumab alone (monotherapy) in adults with moderately to severely active Crohn's Disease. The main goal is to see if DTT better reduces bowel inflammation and ulcers after 12 weeks of treatment. This Phase 3b trial involves about 396 participants worldwide and also aims to assess the long-term safety and efficacy of these treatments. Participants are randomly assigned in equal numbers to receive either vedolizumab plus upadacitinib or vedolizumab plus placebo during a 12-week induction phase. Those who respond well, showing a significant reduction in disease activity, then continue to a 40-week maintenance phase receiving vedolizumab alone. After this, participants undergo an 18-week safety follow-up period, making the total study participation approximately 70 weeks. During the study, participants will visit the clinic 15 times for assessments including evaluations of disease activity, endoscopic examinations, and safety monitoring. The main outcome measures include the percentage of participants achieving clinical remission and showing improvement in bowel inflammation at Week 12. Researchers will track effectiveness, adverse effects, and overall health throughout the treatment and follow-up periods.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer (NSCLC) who have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are evaluating the combination of BMS-986504, pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in people with first-line metastatic non-small cell lung cancer who have a homozygous MTAP deletion. The study is a randomized phase 2/3 trial focused on assessing clinical benefits in this specific patient group. Participants will receive either BMS-986504 with pembrolizumab and chemotherapy or placebo with pembrolizumab and chemotherapy. The chemotherapy may include drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on specified days. This treatment is administered as part of the first-line therapy for metastatic disease. During the study, researchers will monitor progression-free survival up to 2 and 5 years using RECIST v1.1 criteria and overall survival up to 5 years. Participants will be assessed regularly for disease progression and survival outcomes. The study includes detailed monitoring to evaluate the effects and safety of the treatment combination over time.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are evaluating the safety, feasibility, and effectiveness of using the Episurf Episeal talus implant in patients aged 20 to 60 years who have osteochondral ankle injuries that have not improved with prior treatments. This pilot study focuses on patients with focal cartilage damage in the ankle that affects pain, mobility, and joint function. The study aims to assess outcomes such as revision surgery rates, complications, pain relief, joint function, and quality of life over a two-year period. Participants will undergo a customized surgical procedure where the damaged cartilage and adjacent bone in the ankle are replaced with a patient-specific metal implant designed from advanced imaging and 3D modeling. This implant aims to closely match the patient’s original joint surface to relieve pain and improve function. Following surgery, patients will receive standard postoperative care including pain management, rehabilitation, and physiotherapy. The study follows patients clinically at 6 weeks, 6 months, 1 year, and 2 years after surgery. Throughout the study, data on clinical function, pain levels, and patient satisfaction will be collected using standardized scoring systems such as the AOFAS ankle score, numeric rating scales, and the EQ-5D-5L quality of life questionnaire. Additional assessments include demographic and clinical data collection, imaging exams, and monitoring for any complications or revision surgeries during the entire 24-month follow-up. The results will provide insights into the implant’s potential benefits and help guide future treatment of ankle cartilage injuries.