Clinical trial NCT03655977: Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in Patients With Cervical Cancer
Official title: Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer
Treatment planning
PET/MRI imaging
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main goal of this project is to evaluate the potential and feasibility of hybrid PET/MRI functional imaging to non-invasively measure tumor characteristics for radiation therapy planning (RT) for cervical cancer. It will be assessed how the complementary information of tumor characteristics can contributed to better understanding of tumor delineation. Another endpoint of this study is to evaluate a new PET-tracer (68Ga-NODAGA- E\[c(RGDyK)\]2) enabling imaging of tumor-angiogenesis.

Detailed description: The standard treatment for patients with locally advanced cervical cancer includes a combination of external beam radiotherapy (EBRT) and brachytherapy (BT) with concurrent cisplatin-based chemotherapy. During the last decade, the utilization of MRI for planning of EBRT and BT has grown based on the GEC ESTRO recommendations and the cervix is among the first cancer sites where response-adaptive radiotherapy has been successfully implemented in clinical practice. This approach has changed patterns of clinical practice with regard to dose administration, and significant improvements in clinical outcome have been reported. However further development of both BT and EBRT is still demanded to improve tumor delineation and consequently local control.

Recent developments in advanced image guidance for both EBRT and BT have potential to improve local as well as nodal and also systemic control. Multi-parametric PET/MR imaging potentially offers new possibilities for RT planning, whereas a complete replacement of the planning MRI with combined PET/MRI for EBRT and BT, alters target volume delineation due to superior soft tissue contrast provided by MRI and combined with the information of tumor heterogeneity, perfusion characteristics, and hypoxia provided by PET, DW-MRI, and DCE-MRI. However combined use of PET/MRI for treatment planning still remains challenging due to several aspects. Therefore, investigators intend to encounter the technical challenges regarding dose planning and attenuation correction of MRI hardware and immobilization devices by generating Pseudo-CT, using methods based on ultra-short echo time (UTE) MR sequence. Additionally, investigators desire to assess how the complementary information provided by multi-parametric PET/MRI can affect the planning of EBRT and BT and contribute to better understanding of the pathology of cervical cancer during chemo-radiotherapy and improve radiation treatment.

The PET/MR will be performed with a new PET-tracer "RGD" (68Ga-NODAGA- E\[c(RGDyK)\]2) enabling imaging of tumor-angiogenesis. This is to show the angiogenesis within the tumor and changes during external radiotherapy. The study of angiogenesis will be supported by examination of tissues from the tumor.

Investigators expect the angiogenesis to correlate to the aggression and thereby the prognosis of the individual tumor.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with cervical cancer stage
* Tumor \> 1cm
* Referred for EBRT and BT planning
* Age \> 18 years
* Informed consent

Exclusion Criteria:

* Prior RT of the pelvic region
* Pregnancy and lactation
* Claustrophobia
* MR-incompatible implants

Primary outcomes:
measure: Feasibility of PET/MRI in radiation treatment planning workflow
timeFrame: 1 year
measure: Measure of angiogenesis with 68Ga-NODAGA-E[c(RGDyK)]2 radio-tracer in patient with cervical cancer
timeFrame: 1 hour
Secondary outcomes:
measure: Feasibility of dose planning using MRI
timeFrame: 1 year
measure: Changes in PTV between conventional MRI and PET/MRI
timeFrame: 1 month
measure: measuring tumor metabolism using Standard Uptake Value (SUV).
timeFrame: 1 hour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Copenhagen
Study officials:
affiliation: Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
name: Barbara Malene Fisher
role: STUDY_DIRECTOR
References: