NCT02824419

Brief Summary

The goal of the current study is to evaluate the potential of the selected PET tracers to detect sarcoidotic lesions in lungs. The tracers are already in clinical use for the detection of certain inflammatory processes or malignant tumors, and their targets present similarities with molecular mechanisms of sarcoidosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

May 27, 2016

Last Update Submit

July 1, 2016

Conditions

Pulmonary Sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.

    Qualitative assessment of tracer uptake in sarcoidotic lesions.

    baseline

Study Arms (2)

C11-methionine

EXPERIMENTAL

To compare FDG and C11-methionine in the detection of sarcoidotic lesions.

Drug: Methionine

68Ga-Dotanoc

EXPERIMENTAL

To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions.

Drug: DOTANOC

Interventions

MethionineDRUG

Subject undergoes imaging studies with FDG and with methionine.

Also known as: PET tracers
C11-methionine
DOTANOCDRUG

Subject undergoes imaging studies with FDG and with DOTANOC.

Also known as: PET tracers
68Ga-Dotanoc

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with sarcoidosis

You may not qualify if:

  • any malignant disease
  • any significant other inflammatory or infectious disease affecting lungs
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Southwest Finland, 20520, Finland

RECRUITING

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

Methionine68Ga-DOTANOC

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesSarcoidosisLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino Acids, EssentialAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Neutral

Study Officials

  • Juhani Knuuti, MD, PhD

    Turku PET Centre, Turku University Hospital, Turku, Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Riikka Lautamaki, MD, PhD

CONTACT

+3582 3130000riikka.lautamaki@tyks.fi

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

July 6, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)