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TerminatedNCT03057743Updated Nov 18, 2021

Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer

An observational study in METASTATIC BREAST CANCER, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-18.

Sponsored by Abramson Cancer Center at Penn Medicine · Observational

Why this study was terminated
Difficulty enrolling subjects
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4
Ages
18 Years and older
Sex
Female
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Study summary

Pilot study using [18F]ISO-1 PET/CT to image sigma-2 receptor binding in metastatic breast cancer. Correlate baseline uptake and change in uptake after therapy with time to progression and standard and experimental pathology assays of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18 years, with at least one site of disease outside the liver by at least one type of standard imaging.

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Conditions studied

  • METASTATIC BREAST CANCER

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 4 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

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Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Metastatic Breast Cancer

Inclusion criteria

  • At least 18 years of age
  • Biopsy proven or clinically documented metastatic breast cancer with at least one lesion outside the liver by standard imaging (e.g. CT, MRI, Bone Scan, Ultrasound, FDG PET/CT)
  • Plan to start new systemic therapy for metastatic disease.
  • Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion criteria

Exclusion Criteria:

  • Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening.
  • Inability to tolerate imaging procedure in the opinion of an investigator or treating physician.
  • Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4 participants (actual)
Patient registry
No

Interventions

  • DevicePositron emission tomography (PET/CT) imaging
  • Deviceradiotracer [18F]ISO-1
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What researchers measure

Primary outcomes

  1. Progression free survival

    Time frame: 3 years

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Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19004, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03057743
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Feb 20, 2017
Start date
Apr 5, 2016
Primary completion
Nov 1, 2021
Completion
Nov 1, 2021
Last update
Nov 18, 2021

Study contacts

Elizabeth MdDonald, MD, Ph.D
principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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