Trial record 10 of 662 for:    ovarian cancer | Open Studies

Dual PETOvac - Dual Time PET/CT in the Preoperative Assessment of Ovarian Cancer

This study is not yet open for participant recruitment.
Verified June 2013 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Mie Holm Vilstrup, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01889615
First received: June 26, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

The investigators want to compare the use of MRI with PET/CT preformed after 1 hour and 3 hours in preoperative assessment of resectability.

The investigators' hypothesis is that dual time PET/CT performed at 60 and 180 minutes will increase the diagnostic accuracy of conventional PET (performed at 60 minutes) in preoperative assessment of resectability.

Further more the investigators suggest that the GLUT/G6Pase index correlates to the SUVmax. And retention index (RI, see Methods - PET protocol) is a prognostic marker in ovarian cancer.


Condition Intervention
Ovarian Cancer
Other: PET/CT(3hours]

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Dual PETOvac - Dual Time PET/CT in the Preoperative Assessment of Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • To find the accuracy in MR, PET/CT 1h and 3h preoperative assessment of ovarian cancer resectability(PET/CT[1]) of the radioactive tracer FDG with PET/CT performed after 3 hours (PET/CT[3]) in a group of patients with high suspicion of ovarian cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    At biweekly multidisciplinary meetings patient resectability is assessed based on disease spread by using conventional PET/CT and MR. The MR, PET [1 hour] vs. PET [3 hours] in assessment of disease spread compared to peroperative findings.


Secondary Outcome Measures:
  • To compare SUVmax with the expression of GLUT1, hexokinase and G6Pase in tumors [ Time Frame: Immediately after surgery ] [ Designated as safety issue: No ]
    To compare the SUVmax measured on PET[1hour] and PET[3hours]with the measured expression of GLUT1, hexokinase II and G6Pase in primary tumors and metastasis


Other Outcome Measures:
  • To compare SUVmax, RI, tumor/liver ratio and GLUT1/G6Pase as a prognostic marker [ Time Frame: 5 years follow up ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue samples from the ovarian cancer and metastasis


Estimated Enrollment: 180
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Suspected ovarian cancer
dual time PET/CT
Other: PET/CT(3hours]
Low dose PET/CT 1 and 3 hours after injection of FDG, followed by a diagnostic CT with iv contrast
Other Name: Dual time PET/CT: PET 1 and 3 hours after injection of FDG

Detailed Description:

The use of PET/CT in ovarian cancer has not been well-established.

The diagnosis usually includes physical examination (incl. pelvic examination), blood test incl. CA-125 and transvaginal ultrasound. Furthermore imaging includes CT of thorax/abdomen and/or MR of pelvic. Ninety per cent of the ovarian cancers are epithelial carcinoma (EOC), which can be divided into serous (45%), mucinous (4%), endometrioid (5%), clear cell, undifferentiated and mixed types. All EOC are treated equally.

Treatment of ovarian cancer involves surgery and chemotherapy. The decision of operability is made at the multidisciplinary conference. Prognosis depends not only in the stage and histological type of the tumor but also at the end result of surgery. Residual disease after initial surgery is a strong prognostic factor for survival, with improvement on both overall and progression free survival being greatest in women with no or minimal (tumor < 1 cm) visible disease at the end surgery. Supra radical surgery is a radical procedure plus e.g. extensive peritonectomy, resection of liver metastases, splenectomy, resection of the tail of pancreas and bowel resection. Only 60% of patients in advanced stage ovarian cancer are deemed optimal debulked peroperative. Patients with optimal debulking have a 5 year survival of 42% versus patients not possible of achieve radical operation with 5 year survival of 15%, resulting in a hazard rate of 2,12 for optimal vs. not optimal debulking. A correct preoperative assessment is important in planning of operation and to avoid futile operation in patients not resectable.

Preoperative CT has shown to have a predictive value in assessment of the completeness of cytoreduction. But also PET/CT is has shown to be a independent predictor of resectability. Currently MR is standard in evaluating patient operability.

Studies has shown PET/CT to be particularly useful in distinguishing patients with stages I-IIIB and IIIC-IV, with an accuracy of 98% compared to 88% with CT alone. The latter group is important to identify because optimal debulking often is not possible and they will benefit from preoperative chemotherapy. Currently the use of PET/CT in staging ovarian cancer is controversial, mainly because of the relatively low specificity, due to FDG-uptake in inflammatory cells and benign lesions. The concordance of PET/CT and surgical staging of ovarian cancer have been reported to range from 69% to 78%.8,9, And a recent study found good correlation between PET/CT findings and laparoscopy but a high rate of false negative results in lesions < 5 mm. But dual time point imaging is maybe the solution to this problem. Today it is standard to perform PET/CT scan 60-90 minutes after injection of tracer. Theoretically, you should get increased tumor/background ratio by performing a late scan, thus better being able to distinguish between malignant and benign. Dual time imaging studies in head and neck cancers, breast cancer and lung cancer suggests improvement in diagnostic accuracy of PET. But the use of delayed imaging in ovarian cancer has not been studied.

The tracer used in PET is 18F-fluoro-2-deoxy-d-glucose. Generally cancer cells are thought to have low or absent G6Pase expression compared to normal cells and cancer cells have increased expression of GLUT (especially GLUT1) and hexokinase (especially HK2), which further leads to intracellular trapping of FDG-6-phosphate in malignant cells and there by yielding high maximum standardized uptake value (SUVmax). But ovarian cancers have found to have a relatively low ratio of hexokinase/phosphatase maybe explaining the low/absent rise in FDG-uptake. The amounts of GLUT, hexokinase and G6Pase are responsible for the FDG trapping intracellular and the retention on the late scans.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ovarian cancer

Criteria

Inclusion Criteria:

  • Suspicion of ovarian cancer
  • Referred to Department of Gynecology, OUH

Exclusion Criteria:

  • Unable to corporate to MR
  • Diabetes Mellitus
  • Prescan glucose level > 10 mmol/l (PET)
  • non-ovarian cancer (incl. benign)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01889615

Contacts
Contact: Mie H Vilstrup, MD + 45 2159 3008 mie.holm.vilstrup@rsyd.dk
Contact: Poul Flemming Høilund-Carlsen, MD, DMSc, Professor +45 3016 1445 pfhc@rsyd.dk

Locations
Denmark
Department of Nuclear Medicine Not yet recruiting
Odense C, Fünen, Denmark, 5000
Contact: Mie H Vilstrup, MD    +45 2159 3008    mie.holm.vilstrup@rsyd.dk   
Principal Investigator: Mie H Vilstrup, MD         
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Mie H Vilstrup, MD Department of Nuclear Medicine, Odense University Hospital
  More Information

No publications provided

Responsible Party: Mie Holm Vilstrup, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01889615     History of Changes
Other Study ID Numbers: NMA K70 Dual PETOvac
Study First Received: June 26, 2013
Last Updated: June 27, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Ovarian cancer
PET/CT
glucose 6 phosphatase

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 15, 2014