Image

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

Recruiting
18 years of age
Both
Phase 1

Powered by AI

Overview

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

Eligibility

Inclusion Criteria:

  • Diagnosis of cancer with radiographic finding of brain metastasis
  • Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
  • Planned treatment with SRS as per the treating physician team
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET

Exclusion Criteria:

  • Prior anaphylactic reaction to 18F-fluciclovine
  • Radiographic evidence of leptomeningeal disease
  • Prior whole-brain radiation therapy
  • Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
  • Pregnant or positive serum pregnancy test within 14 days of registration
  • Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.
  • Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent*
    • A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.

Study details

Brain Metastases, Brain Metastases, Adult, Brain Cancer

NCT06048094

Baptist Health South Florida

29 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.