Fibromatosis

Researchers are evaluating the drug ES014 in adults with desmoid tumors in this open-label, multicenter, single-arm phase 2 clinical study. The study aims to assess the effectiveness, safety, tolerability, patient-reported outcomes, pharmacokinetics, pharmacodynamics, and immune response to ES014 in this patient population. Participants will receive ES014 through intravenous infusion at doses of either 700 mg or 1400 mg every 14 days. The study design includes two experimental arms with these dosing regimens. Treatment will be given over a period of 1 to 3 years while monitoring the patients closely for response and side effects. During the study, participants will undergo evaluations including tumor response assessments according to RECIST 1.1 criteria, safety and tolerability checks, pharmacokinetic testing, and immune response measurements. Researchers will track patient-reported outcomes and monitor for adverse effects throughout the study duration. The primary outcome is the objective response rate measured by an independent review committee over 1 to 3 years.

The trial focuses on improving soft tissue healing around dental implants, which is crucial for long-term success and aesthetics. Researchers are studying the use of topical oxygen therapy applied around customized healing abutments to better understand its effect on tissue regeneration, including linear and volumetric changes. This phase 4 study aims to provide clinical evidence to guide dental professionals in enhancing implant soft tissue management. Participants will undergo a thorough preoperative assessment including medical history, clinical and radiographic evaluations, and oral hygiene instruction before second-stage implant surgery. During surgery, a customized PEEK healing abutment is placed on the implant. Blue®M oral gel, which delivers topical oxygen, is applied around the healing collar immediately after placement and continued twice daily for 7 days. Standard postoperative care including chlorhexidine mouthwash and pain management is provided. Participants will be monitored with clinical evaluations at baseline, day 7, and day 21 to assess soft tissue changes, pain, wound healing, and clinical photographs. The main outcomes measured are soft tissue dimensional changes and the Pink Esthetic Score at baseline, 3 months, and 6 months post-treatment. Secondary outcomes include postoperative pain and wound healing assessments at days 1, 3, and 10. The total participation period covers these follow-ups to evaluate the therapy's impact.

Desmoid fibromatoses are rare, locally aggressive tumors that arise from mesenchymal tissue. This research focuses on evaluating chemoembolization using Doxorubicin delivered through arterial embolization as a treatment for symptomatic and actively growing desmoid fibromatosis, especially in patients unsuitable for surgery or cryoablation. Current treatment guidelines favor active surveillance for asymptomatic cases and reserve chemotherapy for more severe presentations due to associated systemic risks. The study investigates chemoembolization, a procedure involving selective catheterization of arteries supplying the tumor and injecting hydrogel microspheres loaded with Doxorubicin. This approach aims to deliver high drug concentrations directly to the tumor site while minimizing systemic exposure. The procedure includes diagnostic arteriography to confirm successful embolization by occluding over 90% of the tumor's blood supply. Participants will be monitored over one year to assess outcomes such as tumor volume reduction, pain relief using VAS scores, and decreased need for pain medications. Quality of life improvements will also be evaluated using standardized questionnaires. Safety and procedural success will be tracked through imaging and clinical assessments throughout the study, with the total participation duration spanning one year.

Researchers are evaluating treatments for desmoid tumors (DT) that progress after an initial period of watchful waiting, which is currently the standard care. This phase II randomized trial compares cryoablation, a procedure that freezes the tumor, with medical therapy using chemotherapy drugs. The trial also includes a cross-over design, allowing patients to receive cryoablation if needed after initial treatment. Participants are assigned to one of two groups: one receives a single cryoablation procedure on Day 0, while the other receives chemotherapy chosen by the investigator. Chemotherapy options include methotrexate plus vinblastine given weekly by intravenous infusion for the first 6 months and less frequently afterward, or vinorelbine taken orally for 12 months, with doses adjusted for adults and adolescents. The study aims to assess treatment effects over several months, including the possibility of switching treatments. During the study, participants undergo regular assessments including MRI scans to measure tumor response, pain evaluations, quality of life questionnaires, and monitoring for side effects. Researchers will measure the rate of disease control at 12 months and track progression-free survival and treatment-related adverse events up to 39 months. Health economics and patient-reported outcomes are also evaluated, with ongoing follow-up to understand long-term effects.

Desmoid tumors are benign growths that can recur locally after surgery and have an unpredictable course. Because of this, treatment has shifted away from surgery toward careful observation or medical therapies such as hormonal treatments and low-dose chemotherapy. This study aims to evaluate cryotherapy as a minimally invasive treatment option to avoid chemotherapy, especially in younger patients with desmoid tumors. The treatment under study is cryotherapy, which involves using anesthesia and imaging-guided percutaneous probes to freeze the tumor tissue. The probes create ice spheres up to 3 cm in size to thoroughly treat the tumor. This procedure is done under CT control to ensure accuracy and safety. Participants will be monitored to assess their response to cryotherapy starting from the baseline before treatment. The study measures how the tumor responds to this treatment over time. Participants will undergo necessary evaluations and imaging to track treatment effects and safety. The total duration and follow-up details are based on individual patient progress and response.

Dupuytren's contracture is a condition causing progressive finger stiffness due to fibrosis in the palm and fingers. This trial investigates whether using a night splint after a minimally invasive procedure called percutaneous needle fasciotomy (PNF) reduces the chance of the contracture coming back. The study compares two groups of patients receiving PNF treatment to see if night splinting adds benefit beyond physical therapy alone. Participants are randomly assigned to one of two groups: one group will receive usual care including physical therapy and night splinting for three months after PNF, while the other group will have physical therapy without night splinting. Those in the no splint group will have an additional check three weeks after PNF to monitor finger extension. Follow-up visits occur at 2 weeks, then 3, 12, and 36 months after treatment. During the study, patients will undergo physical exams assessing finger motion, sensation, and grip strength. They will also complete questionnaires about hand function, pain, and quality of life at several timepoints including the day of procedure and months 3, 12, and 36. The main outcome measured is reduction in finger joint contracture at 1 year. Researchers will also evaluate changes in finger flexion, grip strength, pain levels, disability, sensation, and medical history over the follow-up period.

Researchers are evaluating whether percutaneous needle aponeurotomy is not less effective than open surgery with aponeurectomy for treating flexion contracture caused by Dupuytren's disease. This condition involves fibrosis of the palmar aponeurosis, leading to disabling joint contractures in the fingers. The study aims to determine if the minimally invasive needle procedure can reduce the need for open surgery while maintaining suitable safety and efficacy. Participants will be randomly assigned to receive either percutaneous needle aponeurotomy, which involves cutting the fibrotic cord with a needle under local anesthesia in one to three outpatient sessions, or open surgery with excision of the fibrotic tissue performed under regional anesthesia during a short hospital stay. Postoperative care including analgesics, splints, nursing, and physiotherapy is provided after surgery. Treatment completion is defined as the last needle session or stitch removal after surgery. Participants will be followed up at 1 week, 1, 3, 12, 24, and 36 months after treatment. Assessments include measuring joint contractures, range of motion, functional limitation questionnaires, patient satisfaction, complications, and recurrence. Efficacy assessments are conducted in a blinded manner, while complications are evaluated openly. The primary outcome is the degree of metacarpophalangeal joint contracture during passive extension at 3 months post-treatment.

Dupuytren's disease is a common hereditary condition in Northern Europe that causes progressive fibrosis in the hand's palmar aponeurosis. This fibrosis leads to bending of the fingers, resulting in significant functional impairment. Various medical and surgical treatments exist, but none fully prevent recurrence of the disease. This trial investigates whether adding autologous adipose tissue grafting to open aponeurectomy can reduce the 2-year recurrence rate of Dupuytren's disease compared to aponeurectomy alone. The study compares two groups: one receiving standard open aponeurectomy alone and the other receiving aponeurectomy combined with adipose tissue grafting. The grafting involves harvesting fat from the arm and injecting it into areas where fibrotic cords were removed, aiming to reconstruct tissue and potentially inhibit fibrosis. Both procedures are performed under anesthesia and follow standard surgical safety practices. Participants will be monitored over several years to assess recurrence rates at 2, 3, and 5 years after surgery. Other evaluations include scar appearance, complication rates shortly after surgery, occurrence of algodystrophy, and quality of life impacts at multiple time points. Researchers will conduct follow-up visits to collect data on these outcomes and overall safety, with participant involvement lasting up to five years post intervention.

Researchers are evaluating the use of Fibroblast Activating Protein (FAP) PET/CT imaging to detect fibrosis caused by various medical conditions where fibrosis is believed to lead to harmful effects and poor outcomes. This phase 1 basket protocol includes patients with fibrosis-inducing diseases such as cancer-associated fibrosis, post-infection, post-radiation, pre or post-transplant, and fibrosis affecting the heart, liver, kidneys, or lungs. The study aims to expand with additional imaging groups as needed to gather clinical data supporting the use of FAP-targeted therapies. Participants will receive an intravenous injection of approximately 6.0 to 8.0 mCi of the radiopharmaceutical [F-18]-FAPI-74, which binds to fibroblast activating protein and allows visualization via PET/CT scan from head to mid-thigh. Some participants may have a second PET/CT scan at a later time to observe changes in fibrosis naturally or in response to therapy. The study includes specific cohorts such as head and neck cancer, post tubercular lung disease, cardiac sarcoidosis, and an exploratory group. During the study, participants will undergo PET/CT imaging sessions to measure the distribution and uptake of [F-18]-FAPI-74 in tissues affected by fibrosis. Imaging results will be compared with clinical pathology and laboratory tests related to fibrosis. The study does not use imaging results to guide treatment decisions, which remain the responsibility of the treating physicians. The primary outcomes focus on PET/CT image analysis over three years. Participation requires informed consent and adherence to imaging procedures.

Researchers are evaluating FOG-001 for safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity in people with locally advanced or metastatic solid tumors that likely or known to have mutations activating the Wnt pathway. This first-in-human, phase 1/2, multicenter study includes dose escalation and expansion phases to assess FOG-001 alone and in combination with other cancer drugs. FOG-001 is given either intravenously or subcutaneously in continuous 28-day cycles. Some participants receive FOG-001 alone, while others receive it combined with mFOLFOX-6, Nivolumab, Trifluridine/tipiracil, or Bevacizumab according to prescribing information. Multiple study parts include treatment of various cancers such as colorectal, hepatocellular carcinoma, desmoid tumors, and prostate cancer, based on specific mutation status. Participants will undergo safety evaluations including monitoring for adverse events and dose-limiting toxicities over approximately 10 months. Tumor response is assessed regularly using imaging criteria, along with specific measurements like PSA30 for prostate cancer. Pharmacokinetic and pharmacodynamic tests are done during early cycles. The study involves frequent visits for treatment administration, scans, lab tests, biopsies, and clinical assessments to track treatment effects and safety throughout the study period.