Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model

Endometrium Cancer Clinical Trial

Official title:

Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212910
• Other study ID #: PET/MRI-ONCOGYN
• Status: Recruiting
• Start date: July 23, 2019
• Est. completion date: February 28, 2027

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Stephanie Steidler, PhD
• Phone: +39022643
• Email: steidler.stephanie[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Endometrial cancer (EC) is the most common gynecological malignancy in high-income countries. Prognosis and treatment are dictated by cancer histological subtype and grade coupled with surgical staging as described by Surgical International Federation of Gynecology and Obstetrics (FIGO) staging system. Surgery is the elective standard treatment and used for staging of EC. The purpose of this study is to collect images from a simultaneous PET/MRI study from which to extrapolate a preoperative, non-invasive, prognostic model.

Description:

Magnetic resonance imaging (MRI) is the most frequently used imaging tool in preoperative staging of endometrial cancer. FDG-PET has demonstrated higher sensitivity than MRI in detecting nodal involvement and metastatic disease and is currently used in adjunction to MRI. Distinct MRI and FDG-PET parameters correlate well with tumor aggressiveness and can and have been used as prognostic factors. The Investigators believe that the combination of data from these two imaging techniques, from which different derived tumor features can be extrapolated, can stratify patients in high-risk and low-risk groups already preoperatively. The aim of combined techniques is to collect large amounts of data leveraging advantages of both modalities (MR's strengths in local staging and PET's strengths in nodal staging) in a single scan from which to extrapolate a preoperative, non-invasive, prognostic model.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 101
• Est. completion date: February 28, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histopathological confirmation of a primary endometrial cancer

• age > 18 years

• no contraindication to surgery (comorbidity, contraindication or lack of consent)

• no contraindication to preoperative imaging

• visible tumor at imaging

• signed inform consent.

Exclusion Criteria:

• patients unsuitable for surgical intervention (comorbidity, contraindication or lack of consent, poor performance status)

• age < 18 years, c) inability to complete the needed imaging examination (ie, severe claustrophobia)

• any additional medical condition that may significantly interfere with study compliance

• all the contraindication for MRI (ie, pacemaker).

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrium Cancer

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Kitajima K, Kita M, Suzuki K, Senda M, Nakamoto Y, Sugimura K. Prognostic significance of SUVmax (maximum standardized uptake value) measured by [(1)(8)F]FDG PET/CT in endometrial cancer. Eur J Nucl Med Mol Imaging. 2012 May;39(5):840-5. doi: 10.1007/s00259-011-2057-9. Epub 2012 Feb 17. — View Citation

Nakamura K, Kodama J, Okumura Y, Hongo A, Kanazawa S, Hiramatsu Y. The SUVmax of 18F-FDG PET correlates with histological grade in endometrial cancer. Int J Gynecol Cancer. 2010 Jan;20(1):110-5. doi: 10.1111/IGC.0b013e3181c3a288. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI evaluation	Measure tumor volume and correlate to surgical specimen	0-2 years
Primary	MRI imaging	Changes in ADC normale versus tumor myometrium	0-2 years
Primary	MRI imaging evaluation	Depth of myometrial invasion	0-2 years
Primary	DCE-MRI perfusion parameters	Define tumor perfusion in normal versus tumor myometrium	0-2 years
Primary	MRI	positive lymph node evaluation	0-2 years
Primary	PET imaging evaluation	PET positive lymph nodes	0-2 years
Primary	PET imaging	Tumor/positive lymph node/metastases SUV values	0-2 years
Secondary	Measure tumor angiogenesis	angiogenesis marker, CD1	0-2 years
Secondary	Correlate PET and MRI derived functional and morphological parameters with histology	Imaging derived parameters correlated with histopathology	0-5 years