Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Vastra Gotaland Region
With
* Five days prior to therapy the patient is provided with a central intra venous line and an abdominal catheter will be introduced during laparoscopy. To investigate the access to the whole abdominal cavity and possible catheter leakage, a 99mTc-colloid, will be infused intra peritoneally (IP) within 1.0 L of a gluco-polymer (Extraneal®). * At the day of treatment vital signs will be measured prior to and after the 30 min infusion and at least every second hour during the first 6 hours after infusion, daily for the remainder of the in-hospital stay and at a minimum at 2, 3, 4 and 8 weeks after the IP infusion. Blood samples will be obtained for pharmacokinetic analyses every hour after completion of the IP infusion for 8 hours, then every 6 hours, together with sampling from the i.p. catheter. * SPECT imaging of the whole abdominal cavity and thorax including the thyroid may be performed following completion of the IP infusion and at approx 8 or 20hrs post infusion. * Physical examination and electrocardiogram will be done prior to and 4 weeks after the IP infusion. Clinical biochemical and hematological parameters will be monitored weekly after treatment. Blood samples to evaluate immunogenicity as well as cancer antigen-125 (CA-125) will also be taken at 2 and 8 weeks after treatment. * The first patient will be observed for at least 4 weeks with any observed toxicity is Grade 2 or less, before the additional patient is accrued at the dose level. * Dosimetry safety criteria: Based upon published data on maximal tolerated absorbed dose (Gy) recalculated to equivalent dose (Sv) with the assumption that the relative biological effectiveness (RBE) = 5, a limit for organ doses is defined. If any organ would reach the defined limit the study will be stopped.
Age
18–85
Sex
FEMALE
Healthy volunteers
Not accepted
