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

NCT ID: NCT03655977

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-09-01

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

68Ga-NODAGA-E[c(RGDyK)]2

Intervention Type: DRUG

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 will be administered before external beam radiation therapy (EBRT).

PET/MRI scan instead of only MRI

Intervention Type: DEVICE

Following injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning external beam radiation therapy.

68Ga-NODAGA-E[c(RGDyK)]2

Intervention Type: DRUG

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 will be administered before brachytherapy (BT).

PET/MRI scan instead of only MRI

Intervention Type: DEVICE

Following injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning brachytherapy.

Interventions

68Ga-NODAGA-E[c(RGDyK)]2

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 will be administered before external beam radiation therapy (EBRT).

Intervention Type: DRUG

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.

Intervention Type: DEVICE

68Ga-NODAGA-E[c(RGDyK)]2

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 will be administered before brachytherapy (BT).

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

RGD-PET; RGD-PET

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

heidi ryssel

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Malene Fisher

Role: STUDY_DIRECTOR

Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Locations

University Copenhagen

Copenhagen, , Denmark

Countries

Denmark

Central Contacts

Heidi Ryssel

Role: CONTACT

heidi.ryssel@regionh.dk

+4528727532

Sahar Ahangari

Role: CONTACT

sahar.ahangari@regionh.dk

+45 71624799

Other Identifiers

H-17016438

Identifier Type: -

Identifier Source: org_study_id