Health Condition 1: C778- Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
Conditions
Interventions
Intervention1: Radiogel Brachytherapy: Yttrium-90 Phosphate suspended within a Hydrogel Delivery Vehicle. Single dose.
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Vivos Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Recurrent, biopsy proven, nodal or extranodal solid metastatic tumors 2. Presenting with 1 - 4 sites of nodal mestastasis 3. Minimum Lesion size of 0.5 centimeters 4. Maximum lesion size of 2.0 cm 5. Patients deemed poor candidates for surgical intervention by the members of the institutional multidisciplinary tumor board, or patients who refused surgery. 6. Patients deemed poor candidates for external beam radiation or those who have received EBRT as part of their primary cancer-directed treatment, as determined by radiation oncologists. 7. Subjects who have a negative pregnancy test =48 hours before RadioGel™ administration in persons of childbearing potential. 8. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects eligible for surgical excision of nodal metastases and those who consent for surgical management 2. Candidates suitable and consent for systemic therapy as determined by medical oncologists. 3. Locations of the nodal metastasis that prevents consistent and reliable sonographic visualization for satisfactory needle guidance and delivery of the therapeutic agent 4. Locations of te nodal mestastasis that, in the judgement of the physician, would expose vulnerable structures (arteries, nerves, esophagus) to radiation injury. 5. Enrollment in a conflicting concurrent clinical trial. 6. Patients who are pregnant or breast feeding. 7. Patients with additional conditions which, in medical opinion, could be of a safety concern, interfere with the use of the therpuetic agent, invalidate its effectiveness or interfere with the ability to ascertain the study endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of adverse events will be used to determine the safety of RadioGel. The determination of adverse events will be based on in-person evaluation by the treating physician and verbal reports from the patient whenever an in-person, virtual or telephone contact is established. Symptoms related to nerve function (such as new development of hoarseness), dysphagia, odynophagia, of vascular injury will be evaluated to determine if related to the brachytherapy and clinical adverse events to be recorded include local pain, local infection, persistent skin erythema or ulceration, injury to larynx or esophagus, nerve dysfunction as manifested by voice dysfunction after 24 hours (to account for local anesthetic effect), vascular injury, hemorrhage, development of abnormal fluid collections, venous thrombosis, neuropathic symptoms, aspiration, laryngeal dysfunction, and dysphagia.Timepoint: day 0, day 1, day 7, month 1, month 3, month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume of the target lesion in mm3 will be calculated with the modified ellipsoid formula height multiplied by width multiplied by length and then divided by 2. The percent decrease in volume of the target lesion will be calculated as volume in mm3 at the last measurement divided by the baseline volume in mm3 multiplied by 100, and then subjected to comparison between means.Timepoint: 24 hour;QOL measurements will be compared before and after therapy and subjected to comparison between means.Timepoint: day 0, day 1, day 7, month 1, month 3, month 12;The PET/CT non-target dose will be estimated based on region-of-interest measurement of radiation counts expressed in percent radioactivity outside of the treatment volume. The proportion of positive responses to the therapy will be estimated by the number of partial and complete responses divided by the total number of evaluable patients.Timepoint: 24 hour | — |
Countries
India
Contacts
Public ContactSandip Bali
HealthCare Global Enterprises Ltd
Outcome results
None listed