Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2014-003027-21-AT
EUCTR2014-003027-21-ATActive, not recruitingPhase 1

Open-label, multi center PET/CT (positron emission tomography/computed tomography) study for investigation of safety and diagnostic performance of the 68Ga labeled PET tracer [68Ga]RM2 following a single intravenous administration of 140 MBq (corresponding to = 40µg mass dose) in patients with primary prostate cancer - PET/CT imaging for safety and diagnostic performance of [68Ga]RM2 in patients with primary prostate

Piramal Imaging SA0 sites80 target enrollmentStarted: February 18, 2015Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
80
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Male

Inclusion Criteria

  • •1.Written informed consent.
  • •2.Males = 45 years of age.
  • •3.Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
  • •4.Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan).
  • •5.Patient had a MRI, and [18F]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: [18F]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
  • •6.The MRI and [18F]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with [68Ga]RM2. The maximum interval between MRI and [18F]-choline PET/CT and treatment with [68Ga]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the [68Ga]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
  • •7.No chemotherapy, radiotherapy, biopsy or immune/biologic therapy between MRI and [18F]-choline PET/CT (when performed) and [68Ga]RM2 PET/CT performed or scheduled. NOTE: If MRI is performed after the [68Ga]RM2 PET/CT, no chemotherapy, radiotherapy, biopsy or immune/biologic therapy between [68Ga]RM2 PET/CT and MRI examination is allowed.
  • •8.Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy
  • •9.ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments).
  • •10.Confirmation of adequate function of major organs and systems.
  • •11.No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
  • •12.No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin).
  • •13.Life expectancy of at least 3 months.
  • •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 25
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 55
  • •1.Written informed consent.
  • •2.Males = 45 years of age.
  • •3.Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
  • •4.Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan).
  • •5.Patient had a MRI, and [18F]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: [18F]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
  • •6.The MRI and [18F]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with [68Ga]RM2. The maximum interval between MRI and [18F]-choline PET/CT and treatment with [68Ga]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the [68Ga]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
  • •7.No chemotherapy, radiotherapy, biopsy or immune/biologic therapy between MRI and [18F]-choline PET/CT (when performed) and [68Ga]RM2 PET/CT performed or scheduled. NOTE: If MRI is performed after the [68Ga]RM2 PET/CT, no chemotherapy, radiotherapy, biopsy or immune/biologic therapy between [68Ga]RM2 PET/CT and MRI examination is allowed.
  • •8.Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy
  • •9.ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments).
  • •10.Confirmation of adequate function of major organs and systems.
  • •11.No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
  • •12.No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin).
  • •13.Life expectancy of at least 3 months.
  • •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 25
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 55
  • •1.Written informed consent.
  • •2.Males = 45 years of age.
  • •3.Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
  • •4.Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan).
  • •5.Patient had a MRI, and [18F]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: [18F]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
  • •6.The MRI and [18F]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with [68Ga]RM2. The maximum interval between MRI and [18F]-choline PET/CT and treatment with [68Ga]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the [68Ga]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
  • •7.No chemotherapy, radiotherapy, biopsy or immune/biologic therapy between MRI and [18F]-choline PET/CT (when performed) and [68Ga]RM2 PET/CT performed or scheduled. NOTE: If MRI is performed after the [68Ga]RM2 PET/CT, no chemotherapy, radiotherapy, biopsy or immune/biologic therapy between [68Ga]RM2 PET/CT and MRI examination is allowed.
  • •8.Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy
  • •9.ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments).
  • •10.Confirmation of adequate function of major organs and systems.
  • •11.No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
  • •12.No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin).
  • +7 more not shown

Exclusion Criteria

  • •1.Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of [68Ga]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
  • •2.Known sensitivity to the study drug or components of the preparation.
  • •3.Patient is in custody by order of an authority or a court of law.
  • •4.Patient is a relative of the investigator, student of the investigator or otherwise dependent.
  • •5.Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
  • •6.Unwillingness or inability to comply with the protocol.
  • •7.Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety.
  • •8.Hematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator, i.e. CTC (Common toxicity criteria) toxicities grade > 2. Minor deviations in lab parameters that are considered by the evaluating physician to be not clinically significant with respect to safety or interpretation of study results are not considered an exclusion criterion.
  • •9.History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines).
  • •10.Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration.
  • •1.Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of [68Ga]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
  • •2.Known sensitivity to the study drug or components of the preparation.
  • •3.Patient is in custody by order of an authority or a court of law.
  • •4.Patient is a relative of the investigator, student of the investigator or otherwise dependent.
  • •5.Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
  • •6.Unwillingness or inability to comply with the protocol.
  • •7.Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety.
  • •8.Hematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator, i.e. CTC (Common toxicity criteria) toxicities grade > 2. Minor deviations in lab parameters that are considered by the evaluating physician to be not clinically significant with respect to safety or interpretation of study results are not considered an exclusion criterion.
  • •9.History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines).
  • •10.Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration.
  • •1.Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of [68Ga]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
  • •2.Known sensitivity to the study drug or components of the preparation.
  • •3.Patient is in custody by order of an authority or a court of law.
  • •4.Patient is a relative of the investigator, student of the investigator or otherwise dependent.
  • •5.Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
  • •6.Unwillingness or inability to comply with the protocol.
  • •7.Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety.
  • •8.Hematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator, i.e. CTC (Common toxicity criteria) toxicities grade > 2. Minor deviations in lab parameters that are considered by the evaluating physician to be not clinically significant with respect to safety or interpretation of study results are not considered an exclusion criterion.
  • •9.History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines).
  • •10.Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration.

Investigators

Sponsor
Piramal Imaging SA

Similar Trials

Active, not recruiting
Phase 1
PET/CT (positron emission tomography/computed tomography) imaging using [68Ga]RM2 (radioactive PET tracer) for detection of tumors in patients with primary prostate cancer.Patients with primary prostate cancer in which prostate cancer is histologically confirmed and a prostatectomy is planned.MedDRA version: 18.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2014-003027-21-FIPiramal Imaging SA80
Completed
Phase 1
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy VolunteersDiagnostic Imaging
NCT01205321Life Molecular Imaging SA19
Terminated
Phase 1
Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy VolunteersDiagnostic Imaging
NCT00975299Bayer16
Completed
Not Applicable
An open label positron emission tomography (PET) imaging study using 89Zirconium to investigate the biodistribution of anti-HER3 monoclonal antibody (mAb) GSK2849330 and characterize its dose receptor occupancy relationship in subjects with advanced HER3-positive solid tumorstumorsadvanced solid tumors10027655
NL-OMON44283GlaxoSmithKline15
Completed
Not Applicable
An open label positron emission tomography (PET) imaging study using 89-Zirconium labelled GSK3128349 to investigate the biodistribution and clearance of an albumin binding domain<br>antibody (AlbudAb) GSK3128349 following single dose intravenous administration in healthy male subjects.niet van toepassing
NL-OMON42953GlaxoSmithKline Research & Development Limited8