Single-photon Emission Computed Tomography (SPECT) to Pre... | NCT00997633

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

NCT00997633

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Oct 19, 2009Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Peritoneal Carcinomatosis

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1991

Primary Completion Date

Aug 2004Actual

Completion Date

Aug 2004Actual

First Submitted Date

Oct 16, 2009

First Submission Date that Met QC Criteria

Oct 16, 2009

First Posted Date

Oct 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2009

Last Update Posted Date

Oct 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peritoneal carcinomatosis		Patients undergoing cytoreductive surgery and intraperitoneal chemotherapy treatment

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detected volume measured by SPECT compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses

Secondary Outcomes

Measure	Description	Time Frame
The relationship between SPECT, feasibility of SPIC (intraperitoneal chemotherapy), and clinical variables

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cytoreductive surgery and intraperitoneal chemotherapy
Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

74 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haile Mahteme, MD PhD	Dept of Surgical Sciences, University Hospital, Uppsala, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Surgical Sciences, Section of Surgery		S-751 85 Uppsala			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D010534	Peritoneal Neoplasms

Ancestor Terms

ID	Term
D000008	Abdominal Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided