Non-invasive measurement of tumor blood flow using 82Rb PET.

Qualification of 82Rb PET for measurement of tumor perfusion. Uptake in primary prostate cancer vs healthy prostate - RubiPerf

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003185-26-DK

Enrollment

Unknown

Registered

2016-08-26

Start date

2016-10-20

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

Cancer MedDRA version: 19.0 Level: LLT Classification code 10036910 Term: Prostate cancer NOS System Organ Class: 100000004864 MedDRA version: 19.0 Level: LLT Classification code 10065410 Term: Combined positron emission tomogram and computerized tomogram System Organ Class: 100000004848

Interventions

Trade Name: Cardiogen-82 Product Name: Cardiogen-82 Pharmaceutical Form: Injection INN or Proposed INN: Rubidium 82 CAS Number: 8000049-30-1 Other descriptive name: RUBIDIUM (82 RB) Concentration unit

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Prostate cancer population 15 high risk prostate cancer patients referred to 68Ga-PSMA PET/CT. Pausation of medicine according to guidelines for clinical 82Rb PET of the heart Control population 15 male patients referred to 82RB PET/CT of the heart. Pausation of medicine according to guidelines for clinical 82Rb PET of the heart 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Prostate cancer population • Age 85 years • Hormone- or radiationtreatment of prostate cancer (PC) • Radikal prostatektomi • Other malignant diseases than PC • Other severe medical condition Control population • Age 85 years • Known PC or other diseases of the prostate (BPH, prostatitis, elevated PSA ) • Other malignant diseases than PC • Other severe medical condition

Design outcomes

Primary

Measure	Time frame
Main Objective: It is well known that blood flow in tumors are higher than in healthy tissue. The main objective of the trial is to prove that the increased blood flow in tumors can be detected by the PET flow tracer 82Rb. In this project we examine the prostate.;Secondary Objective: Not applicable;Primary end point(s): Primary end point is difference between SUV of 82Rb PET in healthy tissue and in tumor tissue. In this study healthy prostate tissue and PC.;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: It is well known that blood flow in tumors are higher than in healthy tissue. The main objective of the trial is to prove that the increased blood flow in tumors can be detected by the PET flow tracer 82Rb. In this project we examine the prostate.;Secondary Objective: Not applicable;Primary end point(s): Primary end point is difference between SUV of 82Rb PET in healthy tissue and in tumor tissue. In this study healthy prostate tissue and PC.;Timepoint(s) of evaluation of this end point: End of study

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactDept. of Nuclearmedicine & PET

Aarhus University Hospital

madsjoch@rm.dk004578456210

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 22, 2026