Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in patients with cervical cancer

Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in patients with cervical cancer - RaPiCCa

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003072-12-DK

Enrollment

Registered

2018-09-03

Start date

2019-02-05

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer MedDRA version: 20.0 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10008233 Term: Cervical cancer stage I System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10008234 Term: Cervical cancer stage II System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10008235 Term: Cervical cancer stage III System Organ Class: 10

Interventions

Product Name: 68Ga-NODAGA- E[c(RGDyK)]2 Product Code: 68Ga-NODAGA- E[c(RGDyK)]2 Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: 68Ga-NODAGA- E[c(R

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria • Diagnosed with cervical cancer stage IB2-IVA • Tumor > 1cm • Referred for EBRT and BT planning • Age > 18 years • Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: ??Exclusion criteria • Prior RT of the pelvic region • Pregnancy and lactation • Claustrophobia • MR-incompatible implants

Design outcomes

Primary

Measure	Time frame
Main Objective: We study patients with cervical cancer stage IB2-IV during radiotherapy treatment. This is carried out by adding angiogenesis PET scan to the usual MR scan. ;Secondary Objective: the prognostic value of angiogenesis PET for predicting progressionfree survival and overall survival. An angiogeneses PET will be performed as a baseline scan before and after external radiation therapy. ;Primary end point(s): angiogenesis PET/MR with the 68Ga-NODAGA- E[c(RGDyK)]2 can be used to visualize cervical tumors, and change as a response to the treatment.;Timepoint(s) of evaluation of this end point: uptake of the radioligand in tumor lesions from angiogenesis PET performed 45 min post injektion of 68Ga-NODAGA- E[c(RGDyK)]2 .	—

Measure

Time frame

Main Objective: We study patients with cervical cancer stage IB2-IV during radiotherapy treatment. This is carried out by adding angiogenesis PET scan to the usual MR scan. ;Secondary Objective: the prognostic value of angiogenesis PET for predicting progressionfree survival and overall survival. An angiogeneses PET will be performed as a baseline scan before and after external radiation therapy. ;Primary end point(s): angiogenesis PET/MR with the 68Ga-NODAGA- E[c(RGDyK)]2 can be used to visualize cervical tumors, and change as a response to the treatment.;Timepoint(s) of evaluation of this end point: uptake of the radioligand in tumor lesions from angiogenesis PET performed 45 min post injektion of 68Ga-NODAGA- E[c(RGDyK)]2 .

—

Secondary

Measure	Time frame
Secondary end point(s): - prognostic information (correlation of 68Ga-NODAGA- E[c(RGDyK)]2 uptake in tumor lesions) - progression free survival - disease free survival - overall survival;Timepoint(s) of evaluation of this end point: - progression free survival (12 month) - disease free survival (12 month) - overall survival (12 month)	—

Countries

Denmark

Contacts

Public ContactHeidi Ryssel

rigshospitalet

heidi.ryssel@regionh.dk004528727532

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026