RECRUITING

Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy

Conditions

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

Primary objective is to assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by CEUS, can predict initial objective response to therapy, defined by current standard-of-care Secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (CEUS or conventional power Doppler or LEAD ultrasound) or optimal time point to predict initial objective response and to assess the correlation of tumor perfusion parameters with change in overall tumor burden, change in diameter on a per-lesion basis, and with 12-month progression-free survival (PFS).

Official Title

Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy

Quick Facts

Study Start:2022-03-21
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05206942

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * pathology-confirmed diagnosis of cancer
  3. * at least one solid tumor lesion greater than 1 cm in diameter (primary tumor and/or at metastatic site), amenable to ultrasound imaging
  4. * planned to be treated with ICI therapy (single agent or in combination with any other drug)
  5. * written informed consent.
  6. * prior use of any ICI is not necessarily excluded, and patients may be included with the approval of the Protocol Director
  1. * known hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG)
  2. * any comorbid condition\*\* that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study

Contacts and Locations

Study Contact

Christian R Hoerner
CONTACT
650-721-3206
hoerner@stanford.edu

Principal Investigator

Alice C. Fan, MD
PRINCIPAL_INVESTIGATOR
Stanford University
Jeremy Dahl, Ph.D
PRINCIPAL_INVESTIGATOR
Stanford University
Aya Kamaya, M.D
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford
Palo Alto, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Alice C. Fan, MD, PRINCIPAL_INVESTIGATOR, Stanford University
  • Jeremy Dahl, Ph.D, PRINCIPAL_INVESTIGATOR, Stanford University
  • Aya Kamaya, M.D, PRINCIPAL_INVESTIGATOR, Stanford 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 Date2022-03-21
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-03-21
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor