Prognostic and Diagnostic Added Value of Medical Imaging in Gynecological Cancer (PRODIGYN)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRegion Västerbotten
About this trial
The goal of this observational study is to learn about the added diagnostic and prognostic value of advanced medical imaging procedures in cervical cancer, endometrial cancer and ovarian cancer. The main questions it aims to answer are:
* Does advanced medical imaging predict survival? * Can advanced medical imaging improve radiotherapy target planning? * Are advanced medical imaging results associated with risk markers found in tumor tissue?
Participants will
* Undergo four additional imaging procedures, as compared to clinical routine examinations, two at baseline and two after three months. * Be subject to clinical follow-up for five years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previously untreated primary cervical, endometrial, or strongly suspected epithelial ovarian cancer.
Known clinical FIGO stage.
>18 years old.
No other known current or previous malignancy within the last 10 years.
Disqualifiers
Imaging findings suggestive of other primary malignancy.
Previously included suspected epithelial ovarian cancer, later confirmed to be other diagnosis than epithelial ovarian cancer or "cancer abdominis".
MRI incompatible devices or patient unable to undergo MRI.
Trial population
Consecutive patients from the Northern Swedish regions of Vasterbotten, Vasternorrland, Jamtland-Harjedalen and Norrbotten, referred to the gynecological- oncological department of Umea University Hospital with newly diagnosed cervical cancer stage \>1a, endometrial cancer type 2 and/or minimum stage 1, or strongly suspected epithelial ovarian cancer.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
FDG-PET/CT and FDG-PET/MRI
Diagnostic testIntravenous injection of FDG 3 MBq/kg. Intravenous injection of Dotarem 279.3 mg/ml, 0.2 ml/kg.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Cervix cancer1 intervention
Group B: Endometrial cancer1 intervention
Group C: Ovarian cancer1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS) and overall survival (OS)
PFS and OS at 3 months
Time frame
3 months2
Progression-free survival (PFS) and overall survival (OS)
PFS and OS at 6 months
Time frame
6 months3
Progression-free survival (PFS) and overall survival (OS)
PFS and OS at 1 year
Time frame
1 year4
Progression-free survival (PFS) and overall survival (OS)
PFS and OS at 5 years
Time frame
5 yearsSecondary outcomes
1
Incidence of radiation therapy side effects
Incidence of radiation therapy side effects at 3 months
Time frame
3 months2
Incidence of radiation therapy side effects
Incidence of radiation therapy side effects at 6 months
Time frame
6 months3
Incidence of radiation therapy side effects
Incidence of radiation therapy side effects at 1 year
Time frame
1 year4
Incidence of radiation therapy side effects
Incidence of radiation therapy side effects at 5 years
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Västerbotten
Lead sponsor
Umeå University
Collaborator
Source ClinicalTrials.gov