A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer

Part of paid clinical trials in Decatur, Illinois.

Sponsor
Cell>Point LLC
Study ID
NCT01394679
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose) — DRUG
    One injection of Technetium-99m Ethylenedicysteine-Deoxyglucose to yield a target dose of 25 mCi (range of 20-30 mCi)by IV push and less than 1 mg of EC-DG
  • 18 F FDG followed by PET/CT imaging — DRUG
    Single injection of 18 F FDG range of 10-20 mCi

Study Details

The purpose of this study is to determine if the images of the primary lesions of lung cancer and any metastatic lesions seen from the investigational SPECT/CT 99mTC-EC-DG scans are the same as the PET/CT 18F-FDG scans.

Key Dates

Start date
May 1, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
154 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: 18-F-FDG Imaging Agent
    18 F FDG followed by PET/CT imaging
  • Experimental: 99m Tc-EC-DG imaging agent
    99m Tc-EC-DG injection followed by SPECT/CT imaging (target of 20-30 mCi of Tc)and \< 1 mg EC-DG

Primary Outcome Measure

Efficacy:Comparison of 99mTc-EcC-DG SPECT/CT images to 18F-FDG PET/CT images of primary lung cancer lesion and metastatic lesions [ Time Frame: Images will be compared at the core image lab at approximately every 4 to 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Decatur Memorial HospitalDecaturIllinois62526-

Find similar trials in Decatur, IL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Decatur Memorial Hospital· Decatur, IL

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