NCT03484884

Brief Summary

The purpose of this study is to test Cerenkov luminescence imaging, which is a different way to take pictures of thyroid cancer and/or any tumors with (existing or suspected) nodal metastases in the neck, supraclavicular, axillary and/or inguinal region.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress91%
Mar 2018Mar 2027

First Submitted

Initial submission to the registry

March 20, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

9 years

First QC Date

March 20, 2018

Last Update Submit

April 27, 2026

Conditions

Keywords

nodal metastases17-538Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Feasibility of clinical Cerenkov luminescence imaging by achieving satisfactory imaging at least a rate of 80%

    The primary objective is to explore the overall feasibility of clinical Cerenkov imaging on patients with any tumors with nodal metastases (existing or suspected) scheduled for routine clinical FDG PET or 131I therapy.

    Through study completion, an average of 24 hours

Study Arms (1)

Thyroid cancer/nodal metastasis

Participants will have thyroid cancer and nodal metastasis in the neck, supraclavicular, axillary and/or inguinal area.

Diagnostic Test: Cerenkov luminescence imaging.

Interventions

Cerenkov luminescence imaging will be obtained from MSKCC patients who are scheduled for routine FDG PET scan or 131I therapy that emit a continuum of ultraviolet and visible light from the decay of certain radionuclides.

Thyroid cancer/nodal metastasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential participants will be identified by a member of the patient's treatment team, the protocol investigator, or research team.

You may qualify if:

  • Participant is 18 years of age or old
  • Participant must meet one of the following:
  • Patients with thyroid cancer scheduled for thyroid ablation therapy with 131I
  • Patients with any tumors with (existing or suspected) nodal metastases in the neck, supraclavicular, axillary and/or inguinal region who are scheduled to receive a clinical FDG PET/CT scan
  • Patients with metastatic prostate cancer who are schedule for Xofigo therapy with 223Ra
  • Patients scheduled to receive a standard of care 66Ga-DOTA-TATE or \[18f\]-PARPi PET scan in the Nuclear Medicine Clinic
  • Patient undergoing Lu-DOTA TATE treatment in the Nuclear Medicine Clinic

You may not qualify if:

  • Patients imaged for Cerenkov luminescence are going to be required to be in a darkened enclosure for at least 10 minutes and sit still during image acquisition. Any conditions that would prevent this will exclude the patients. This includes patients who unable to sit in a dark environment, have claustrophobic, inability to sit still for a few minutes
  • Any other past medical, physiological or demographic concerns. This includes any patients with skin blemishes that are present at the dermis over the tumor, as these are of particular interest for use of this technique. This also includes open wounds on the area of interest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Pratt EC, Skubal M, Mc Larney B, Causa-Andrieu P, Das S, Sawan P, Araji A, Riedl C, Vyas K, Tuch D, Grimm J. Prospective testing of clinical Cerenkov luminescence imaging against standard-of-care nuclear imaging for tumour location. Nat Biomed Eng. 2022 May;6(5):559-568. doi: 10.1038/s41551-022-00876-4. Epub 2022 Apr 11.

Related Links

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Jan Grimm, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 2, 2018

Study Start

March 20, 2018

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations