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COMPLETED Phase 1

Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA

NCT02865434 · View on ClinicalTrials.gov ↗

Study Summary

Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.

Conditions Studied

Interventions

  • DRUG Tc99m-tilmanocept
  • PROCEDURE SPECT Imaging (60 Minutes post-injection)
  • PROCEDURE SPECT Imaging (180 Minutes post-injection)
  • PROCEDURE Whole body planar SPECT imaging (15 Minutes post-injection)
  • PROCEDURE Whole body planar SPECT imaging (60 Minutes post-injection)

Study Locations (1)

Ohio

  • Kettering Medical Center — Kettering

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2017-01
Est. Completion 2018-06
Phase Phase 1

Sponsor

Navidea Biopharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02865434

The ClinicalTrials.gov registry entry for NCT02865434 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Navidea Biopharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 5 interventions — of which Tc99m-tilmanocept is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02865434 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02865434 about?

NCT02865434 is a clinical study titled "Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA". Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.

What is the current status of trial NCT02865434?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2017-01. Estimated completion is 2018-06.

What conditions does trial NCT02865434 study?

This clinical trial studies the following conditions: Arthritis, Rheumatoid. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02865434?

The interventions under investigation include: Tc99m-tilmanocept (DRUG), SPECT Imaging (60 Minutes post-injection) (PROCEDURE), SPECT Imaging (180 Minutes post-injection) (PROCEDURE), Whole body planar SPECT imaging (15 Minutes post-injection) (PROCEDURE), Whole body planar SPECT imaging (60 Minutes post-injection) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02865434?

This trial is sponsored by Navidea Biopharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02865434 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial