Cervical CancerRaPiCCaNCT03655977
Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in Patients With Cervical Cancer
A study testing 68Ga-NODAGA-E[c(RGDyK)]2 and PET/MRI scan instead of only MRI in people with Cervical Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- 68Ga-NODAGA-E[c(RGDyK)]2 and PET/MRI scan instead of only MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cervical cancer stage
- Tumor > 1cm
- Referred for EBRT and BT planning
- Age > 18 years
- Informed consent
Who cannot join
- Prior RT of the pelvic region
- Pregnancy and lactation
- Claustrophobia
- MR-incompatible implants
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- 68Ga-NODAGA-E[c(RGDyK)]2, PET/MRI scan instead of only MRI
- Keywords
- Cervical cancer, Treatment planning, PET/MRI imaging
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-E[c(RGDyK)]2Drug
Also called RGD-PET
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 will be administered before external beam radiation therapy (EBRT).
PET/MRI scan instead of only MRIDevice
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)]2Drug
Also called RGD-PET
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 will be administered before brachytherapy (BT).
PET/MRI scan instead of only MRIDevice
Following injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning brachytherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer patients | Experimental | This pilot study includes 25 women with histologically proven advanced stage primary cervical cancer (FIGO stages ≥IB2-IVA), planned for treatment with radio-chemotherapy. Receives: Drug: 68Ga-NODAGA-E[c(RGDyK)]2; Device: PET/MRI scan instead of only MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (3)
Feasibility of dose planning using MRI
evaluate the feasibility of performing dose planning based on MRI-only obtained from a PET/MRI system by applying new sequence.
Measured: 1 year
Changes in PTV between conventional MRI and PET/MRI
Compare changes in planning target volume (PTV) and tumor delineation between conventional MRI and PET/ MRI planning.
Measured: 1 month
measuring tumor metabolism using Standard Uptake Value (SUV).
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heidi ryssel, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Barbara Malene Fisher, Study director, Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655977
- Sponsor's protocol ID
- H-17016438
- Acronym
- RaPiCCa
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in Patients With Cervical Cancer
- ClinicalTrials.gov ID
- NCT03655977
- Acronym / sponsor ID
- RaPiCCa / H-17016438
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, Treatment planning, PET/MRI imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer patients | Experimental | Drug: 68Ga-NODAGA-E[c(RGDyK)]2, Device: PET/MRI scan instead of only MRIThis pilot study includes 25 women with histologically proven advanced stage primary cervical cancer (FIGO stages ≥IB2-IVA), planned for treatment with radio-chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with cervical cancer stage
- Tumor > 1cm
- Referred for EBRT and BT planning
- Age > 18 years
- Informed consent
Key exclusion criteria (4 listed)
- Prior RT of the pelvic region
- Pregnancy and lactation
- Claustrophobia
- MR-incompatible implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-E[c(RGDyK)]2Also: RGD-PET200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 will be administered before external beam radiation therapy (EBRT). | Drug | Cervical cancer patients |
| PET/MRI scan instead of only MRIFollowing injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning external beam radiation therapy. | Device | Cervical cancer patients |
| 68Ga-NODAGA-E[c(RGDyK)]2Also: RGD-PET200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 will be administered before brachytherapy (BT). | Drug | Cervical cancer patients |
| PET/MRI scan instead of only MRIFollowing injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning brachytherapy. | Device | Cervical cancer patients |
Primary outcome
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.
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.
3 secondary outcomes
Feasibility of dose planning using MRI
Time frame: 1 year
Changes in PTV between conventional MRI and PET/MRI
Time frame: 1 month
measuring tumor metabolism using Standard Uptake Value (SUV).
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Malene Fisher study director
Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-NODAGA-E[c(RGDyK)]2 and PET/MRI scan instead of only MRI in people with Cervical Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Ryssel (+4528727532, heidi.ryssel@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of PET/MRI in radiation treatment planning workflow (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.