Recruiting
Phase 2

[18F]-ML-10

Sponsor:

Aposense Ltd.

Code:

NCT00805636

Conditions

Brain Metastases

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

2-(5-fluoro-pentyl)-2-methyl-malonic-acid ([18F]-ML-10)

Stereotactic Radio-Surgery (SRS) therapy

Positron Emission Tomography

Study Details

Brief summary:

The purpose of this study is to evaluate the potential of \[18F\]-ML-10 to serve as an imaging tool for the early detection of response of brain metastases to radiation therapy. Such early detection may help early identification of responsive and non-responsive lesions. The experimental design of the present study aims to evaluate the potential of PET imaging with \[18F\]-ML-10 to address the currently unmet clinical need for very early (within one day)assessment of response to therapy. Currently, response assessment is available only after several weeks or months after completion of therapy, when tumor shrinkage can be detected by anatomical imaging (by MRI). Early detection of tumor response to treatment is now widely-recognized as a highly-desirable goal in oncology, and is respectively the target of intense research worldwide. In the future, the option to know early upon treatment administration, that the treated tumor is a non-responsive, may improve clinical management of patients with brain metastases of solid tumors.

Conditions

Brain Metastases

Solid Tumors

Study ID

NCT00805636

Start date

Nov, 2008

Status verified date

Apr, 2010

Completion date

Oct, 2010

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female patients with metastatic non- hematological solid tumors, with one or more brain metastases, of which at least one lesion has a diameter ≥1.5 cm, as confirmed by anatomical imaging (GBCA-enhanced MRI), wherein this lesion (or lesions) is scheduled to be treated by SRS.
2. ECOG performance status of 0, 1 or 2 at the time of enrollment.
3. Women of child-bearing potential must have a negative blood pregnancy test at screening and use an adequate and medically acceptable contraceptive method.
4. Willing and able to follow the protocol requirements.
5. Able to provide written informed consent.

Exclusion Criteria:

1. Unstable medical condition, such as ischemic heart disease, or any other disease or medical condition that may place the patient at added risk during the study, as assessed by the Principal Investigator. A patient with a seizure disorder, focal or generalized, not adequately controlled by anti-convulsant therapy, and /or patient who have experienced an event of focal or generalized seizure within 7 days prior to screening will be considered neurologically unstable.
2. Any indication of a risk for an imminent brain herniation, as evaluated by the Principal Investigator, based on the findings on brain MRI.
3. Treatment with whole brain radiation therapy (WBRT) within 3 months prior to screening.
4. Evidence for hemorrhage within any of the brain metastases.
5. Any known psychiatric disorder other than mild depression or anxiety that may affect adherence to the study requirements.
6. Known allergy to gadolinium.
7. Any contraindication to MR imaging (e.g., metal implant, aneurysm clip, pacemaker).
8. Other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
9. Treatment with any investigational drug, device or biologic agent within 30 days prior to administration of \[18F\]-ML-10.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

2-(5-fluoro-pentyl)-2-methyl-malonic-acid ([18F]-ML-10)

\[18F\]-ML-10 will be radiolabeled at the PET Radioactive Drug Production (RDP) facility at or in close proximity to each clinical site, and will be administered as an intravenous bolus injection (in 3-10 ml sterile saline solution, containing no more than 10% ethanol by volume). The dose concentration selected for \[18F\]-ML-10 will be 7 MBq/Kg or 0.19 mCi/Kg. The radioactivity dosage of \[18F\]-ML-10 administered at each PET/CT session will be at least 300 MBq (8.1 mCi) and not more than 500 MBq (13.5 mCi).

Stereotactic Radio-Surgery (SRS) therapy

SRS will be administered according to the standard of care using a radiation dose of 14-24 Gy to each lesion.

Positron Emission Tomography

Each patient will undergo 2 PET/CT sessions, each following intravenous administration of \[18F\]-ML-10, to assess tracer uptake by the brain metastases treated by SRS. The PET/CT scan will be directed to the brain and will include one bed position. The PET/CT sessions will be performed at baseline, i.e., before the radiation treatment, and on the day after, within 24h after SRS treatment.

Primary outcome measure

  • To assess the relationship between changes in 18FML10 uptake in the target lesions (PET/CT) obtained before and after radiotherapy (SRS), and changes of the lesions size (MRI, ~8w after SRS) in response to treatment, according to the WHO criteria [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Eric Wong, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Stephanie E Weiss, MD

Department of Radiation oncology, Memorial Sloan Kettering Cancer Center

Recruiting

New York city, New York, United States, 10065

Contacts

Gina Giannantoni-ibelli

GiannanG@mskcc.org

Principal Investigator:

Kathryn Beal, MD

UPMC Shadyside Radiation Oncology

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Rhonda Berlin

berlinrL@upmc.edu

Principal Investigator:

Heron Dwight, MD

More Information

Sponsor

Aposense Ltd.

Last update posted

May 12, 2010

Last verified

Apr, 2010

Keywords

  • cell death
  • PET imaging
  • brain metastases
  • stereotactic radiosurgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aposense Ltd. on 2010-05-12.