Peritoneal CarcinomatosisNCT00997633

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

An observational study of Peritoneal Carcinomatosis, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 14 to 74 years
Conditions the study is for: Peritoneal Carcinomatosis
How many people: 51 participants
Where: 1 siteSweden
Study dates: May 1991to Aug 2004
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 74 years
All sexes
No healthy volunteers
Child, Adult, Older 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.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Dept of Surgical Sciences, Section of Surgery
S-751 85 Uppsala

Other trials in Sweden

About this study

Official title: Single-photon Emission Computed Tomography for Prediction of Treatment Results in Sequential Intraperitoneal Chemotherapy at Peritoneal Carcinomatosis

Conditions: Peritoneal Carcinomatosis
Keywords: Intraperitoneal volume, peritoneal carcinomatosis, cytoreductive surgery, SPECT, intraperitoneal chemotherapy
Medical subject headings: Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00997633
Study group	Role	What they receive
Peritoneal carcinomatosis		Patients undergoing cytoreductive surgery and intraperitoneal chemotherapy treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

The relationship between SPECT, feasibility of SPIC (intraperitoneal chemotherapy), and clinical variables

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 1991Aug 2004

First posted19 Oct 2009 (estimated)
Study startMay 1991
Primary completionAug 2004
Study completionAug 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00997633
Sponsor's protocol ID: SPECT IK1991:5
Status last verified: Oct 2009
First submitted: 16 Oct 2009
Last updated: 19 Oct 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 2
Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
Synchronous Gastric Peritoneal Carcinomatosis, Gastroesophageal Peritoneal Carcinomatosis
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
RecruitingPhase 1
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma
Mesothelin Positive, Mesothelin-Expressing Tumors
Active, not recruitingPhase 1
Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer
Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8

All Peritoneal Carcinomatosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-photon Emission Computed Tomography for Prediction of Treatment Results in Sequential Intraperitoneal Chemotherapy at Peritoneal Carcinomatosis
ClinicalTrials.gov ID: NCT00997633
Acronym / sponsor ID: SPECT IK1991:5
Conditions: Peritoneal Carcinomatosis
Keywords: Intraperitoneal volume, peritoneal carcinomatosis, cytoreductive surgery, SPECT, intraperitoneal chemotherapy
Study type: Observational
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Uppsala UniversityUniversity, hospital or other
Study start: May 1991
Primary completion: Aug 2004 (actual)
Study completion: Aug 2004 (actual)
First posted: 19 Oct 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Number of arms: 1

Arm	Type	Receives
Peritoneal carcinomatosis	–	–Patients undergoing cytoreductive surgery and intraperitoneal chemotherapy treatment

Who may qualify

Ages: 14 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older 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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

The relationship between SPECT, feasibility of SPIC (intraperitoneal chemotherapy), and clinical variables

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2009.

Related trials for Peritoneal Carcinomatosis

RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 2
Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
Synchronous Gastric Peritoneal Carcinomatosis, Gastroesophageal Peritoneal Carcinomatosis
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
RecruitingPhase 1
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma
Mesothelin Positive, Mesothelin-Expressing Tumors
Active, not recruitingPhase 1
Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer
Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haile Mahteme, MD PhD principal investigator

Dept of Surgical Sciences, University Hospital, Uppsala, Sweden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peritoneal Carcinomatosis, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detected volume measured by SPECT compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00997633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2009.