Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in Patients With Cervical Cancer
RaPiCCa
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedFirst Posted
Study publicly available on registry
September 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedSeptember 4, 2018
August 1, 2018
3 years
August 2, 2018
August 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of PET/MRI in radiation treatment planning workflow
Assess the feasibility of PET/MRI in the radiation treatment planning workflow with respect to the adequacy of tumor delineation and planning target volume using PET/MRI data as compared to MRI-only planning.
1 year
Measure of angiogenesis with 68Ga-NODAGA-E[c(RGDyK)]2 radio-tracer in patient with cervical cancer
Measure of voxel values, metabolic volume represents angiogenesis volume in patients with cervical cancer. Angiogenesis can be analysed qualitatively.
1 hour
Secondary Outcomes (3)
Feasibility of dose planning using MRI
1 year
Changes in PTV between conventional MRI and PET/MRI
1 month
measuring tumor metabolism using Standard Uptake Value (SUV).
1 hour
Study Arms (1)
Cervical cancer patients
EXPERIMENTALThis pilot study includes 25 women with histologically proven advanced stage primary cervical cancer (FIGO stages ≥IB2-IVA), planned for treatment with radio-chemotherapy.
Interventions
200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 will be administered before external beam radiation therapy (EBRT).
Following injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning external beam radiation therapy.
Eligibility Criteria
You may qualify if:
- Diagnosed with cervical cancer stage
- Tumor \> 1cm
- Referred for EBRT and BT planning
- Age \> 18 years
- Informed consent
You may not qualify if:
- Prior RT of the pelvic region
- Pregnancy and lactation
- Claustrophobia
- MR-incompatible implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Copenhagen
Copenhagen, 2200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Barbara Malene Fisher
Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
August 2, 2018
First Posted
September 4, 2018
Study Start
September 1, 2018
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
September 4, 2018
Record last verified: 2018-08