Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in Patients With Cervical Cancer (RaPiCCa)

August 30, 2018 updated by: heidi ryssel, Rigshospitalet, Denmark
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • University Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cervical cancer patients
This pilot study includes 25 women with histologically proven advanced stage primary cervical cancer (FIGO stages ≥IB2-IVA), planned for treatment with radio-chemotherapy.
Drug: 68Ga-NODAGA-E[c(RGDyK)]2
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 will be administered before external beam radiation therapy (EBRT).
Other Names:
  • RGD-PET
Device: PET/MRI scan instead of only MRI
Following injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning external beam radiation therapy.
Drug: 68Ga-NODAGA-E[c(RGDyK)]2
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 will be administered before brachytherapy (BT).
Other Names:
  • RGD-PET
Device: PET/MRI scan instead of only MRI
Following injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning brachytherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of PET/MRI in radiation treatment planning workflow
Time Frame: 1 year
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
Time Frame: 1 hour
Measure of voxel values, metabolic volume represents angiogenesis volume in patients with cervical cancer. Angiogenesis can be analysed qualitatively.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of dose planning using MRI
Time Frame: 1 year
evaluate the feasibility of performing dose planning based on MRI-only obtained from a PET/MRI system by applying new sequence.
1 year
Changes in PTV between conventional MRI and PET/MRI
Time Frame: 1 month
Compare changes in planning target volume (PTV) and tumor delineation between conventional MRI and PET/ MRI planning.
1 month
measuring tumor metabolism using Standard Uptake Value (SUV).
Time Frame: 1 hour
Tumor metabolism in cancer cells prior to external beam radiation therapy as well as brachytherapy can be measured by SUV which depends on patient weight and injected activity.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Barbara Malene Fisher, Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (ACTUAL)

September 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 4, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17016438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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