Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144853
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-17
Brief Title:
The PIPAC-OPC7 Study The Use of PETCT Scans as a Method of Evaluation in Patients Treated With PIPAC a Pilot Study
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
FDG-PETCT as a Method of Patient Selection and Response Evaluation in Patients With Peritoneal Metastasis Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pilot study will investigate the use of repeated FDG-PETCT scans in 16 patients with peritoneal metastasis originating from abdominal cancers treated with Pressurized Intraperitoneal Aerosol Chemotherapy The study will focus on the potential of repeated FDG-PETCT scans to evaluate the treatment as well as the feasibility in the patient group
Detailed Description:
Background Peritoneal metastasis PM is a late-stage manifestation of several gastro-intestinal cancers Conventional administrated chemotherapy has limited effect due to the peritoneal-plasma barrier and most patients will die from their disease within a few months An alternative treatment strategy Pressurized IntraPeritoneal Aerosol Chemotherapy PIPAC has gained interest in the last decade Prospective phase II studies have demonstrated significant local treatment effect and promising survival data initially within the palliative setting but more recently also with curative intent The technical aspects of PIPAC are nearly uniform worldwide but there is no consensus on the optimal evaluation of treatment response Currently histological features in repeated biopsies from the peritoneum are used as an indicator of treatment response Thus easily accessible and non-invasive alternatives are needed to optimize and personalize patient selection and to improve the response assessment Both are also essential regarding future development and implementation of this treatment for both curative and palliative purposes This could be achieved with the use of imaging techniques Computed tomography CT scan holds well-known limitations in the detection of PM Alternatively several studies have investigated the use of the Positron emission tomography and CT PETCT scans in the diagnostic setting of PM This method shows promising results concerning visualization and assessing PM lesions but no studies have investigated the ability of PETCT scans to detect changes in PM during PIPAC treatment Enabling the use of PETCT scans as an evaluation tool for PIPAC-directed therapy is an important and necessary step to expand the clinical application Also non-invasive evaluation methods and consensus of evaluation is of significant importance for the quality of future randomized controlled trials in this field of research We want to conduct a prospective study to investigate if PETCT scans can detect changes within PM lesions in patients treated with PIPAC directed therapy Since the study is the first of its kind we plan to start with a pilot study including only a few patients We will use the results to generate important knowledge for subsequent larger randomized studies on and clinical optimization of PIPAC directed therapy in patients with PM
Objective To investigate whether FDG-PETCT scans can detect changes in PM in patients treated with PIPAC and whether the repeated scans are feasible within this group of patients
Method The pilot study will include 16 patients with known PM four from each of the groups gastric cancer pancreatic cancer colo-rectal cancer and ovarian cancer will be included The patient will be offered standard PIPAC directed treatment including standard histological evaluation of biopsies of the peritoneum according to local guidelines During the first series one series is equivalent to three PIPAC treatments each five weeks patients will receive three FDG-PETCTs one before PIPAC 1 one after PIPAC 2 and one after PIPAC 3 The scans will be described according to PERCIST PET response criteria in solid tumors In case of FDG-negative PM-disease at the first scan the patient will receive only one follow-up scan after PIPAC 2 to investigate whether the treatment if self can cause FDG-uptake in the PM elements
Objective To investigate whether FDG-PETCT scans can detect changes in PM in patients treated with PIPAC and whether the repeated scans are feasible within this group of patients
Method The pilot study will include 16 patients with known PM four from each of the groups gastric cancer pancreatic cancer colo-rectal cancer and ovarian cancer will be included The patient will be offered standard PIPAC directed treatment including standard histological evaluation of biopsies of the peritoneum according to local guidelines During the first series one series is equivalent to three PIPAC treatments each five weeks patients will receive three FDG-PETCTs one before PIPAC 1 one after PIPAC 2 and one after PIPAC 3 The scans will be described according to PERCIST PET response criteria in solid tumors In case of FDG-negative PM-disease at the first scan the patient will receive only one follow-up scan after PIPAC 2 to investigate whether the treatment if self can cause FDG-uptake in the PM elements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None