RECRUITING

SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated from SPECT images and the outcomes. Patients will be recruited for SPECT/CT imaging during treatment. This is an observational study no additional new drugs or activities will be administrated. The investigators will perform SPECT imaging on a total of 80 patients (\~20 each from year 2 to year 5). Each participant will be imaged 3 times after the first and last cycles of planned radiopharmaceutical therapy.

Official Title

Single-Photon Emission Computed Tomography (SPECT) Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (SEEtoTREAT)

Quick Facts

Study Start:2025-02-03
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06389097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cohort A: Patients with advanced prostate cancer planning to undergo treatment with Radium-223
  2. * Cohort B: Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617
  3. * Age \> 18 years
  4. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  5. * Histologic confirmation of malignancy
  1. * Patient is participating in another research protocol that does not allow participation in this imaging protocol or that has schedule of procedures that would not be compatible with this protocol.
  2. * Patient unable to tolerate SPECT scan time, scan frequency, or position.

Contacts and Locations

Study Contact

Ana Kiess
CONTACT
443-287-7528
akiess1@jhmi.edu
Ryan Manuel
CONTACT
410-955-4261
rmanuel5@jhmi.edu

Principal Investigator

Ana Kiess, MD, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Ana Kiess, MD, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03
Study Completion Date2029-08

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

  • Radium-223
  • 177Lu-DOTATATE
  • 177Lu-PSMA-617
  • SPECT

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Advanced Cancer