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Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997633
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : October 19, 2009
Sponsor:
Information provided by:
Uppsala University

Tracking Information
First Submitted Date October 16, 2009
First Posted Date October 19, 2009
Last Update Posted Date October 19, 2009
Study Start Date May 1991
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2009)
Detected volume measured by SPECT compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 16, 2009)
The relationship between SPECT, feasibility of SPIC (intraperitoneal chemotherapy), and clinical variables
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy
Official Title Single-photon Emission Computed Tomography for Prediction of Treatment Results in Sequential Intraperitoneal Chemotherapy at Peritoneal Carcinomatosis
Brief Summary SPECT was performed in 51 patients after cytoreductive surgery in combination with intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses that could be performed without further surgical intervention. SPECT data was found to predict feasibility of sequential postoperative intraperitoneal chemotherapy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who had undergone cytoreductive surgery and intraperitoneal chemotherapy (SPIC) at the Dept of Surgical Sciences, Uppsala University Hospital in the time period between May 1991 and August 2004.
Condition Peritoneal Carcinomatosis
Intervention Not Provided
Study Groups/Cohorts Peritoneal carcinomatosis
Patients undergoing cytoreductive surgery and intraperitoneal chemotherapy treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 16, 2009)
51
Original Actual Enrollment Same as current
Actual Study Completion Date August 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Cytoreductive surgery and intraperitoneal chemotherapy
  • Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 74 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT00997633
Other Study ID Numbers SPECT IK1991:5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Haile Mahteme, MD PhD, Dept of Surgical Sciences, Section of Surgery, Uppsala University, Sweden
Study Sponsor Uppsala University
Collaborators Not Provided
Investigators
Principal Investigator: Haile Mahteme, MD PhD Dept of Surgical Sciences, University Hospital, Uppsala, Sweden
PRS Account Uppsala University
Verification Date October 2009