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Completed

NCT Number: NCT01916135

PET Imaging of Cancer Patients Using [18F]-SKI-249380, a Radiolabeled Dasatinib-Derivative

This study is the first time that a new experimental drug called [18F]-SKI-249380 is being used in people. [18F]-SKI-249380 is not a therapeutic drug. [18F]-SKI-249380 is a drug that will be used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find tumors in patients.

This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is given to people in tiny amounts by an injection into a vein in their arm, and to see where [18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380 are better for finding tumors compared to the standard types of scans that doctors use.

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Key information

Conditions

Carcinoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Melanoma Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with history of histologically-confirmed neoplasm of any of the following classifications: solid malignancy, myeloid neoplasm, lymphoid neoplasm.
  • Histology confirmed by MSKCC Department of Pathology.
  • Disease that is either:
  • Radiologically-measurable or evaluable as defined by tumor response criteria from an MSKCC-IRB approved clinic research protocol.
  • Detectable by biopsy (eg, bone marrow) and/or peripheral blood assays obtained within 6 weeks of study enrollment
  • Age between 21-90
  • Negative serum pregnancy test for females of child-bearing age (11-55 years) and potential (ie, women who were not postmenopausal before the start of ongoing treatment, if applicable; and who have not had a surgical intervention whose intent or effect is sterilization, such as tubal ligation or hysterectomy.)
  • Not breast-feeding, if applicable.

Exclusion criteria

  • Refusal or inability to discontinue medications or other substances (eg, foods or dietary supplements) that may affect [18F]-SKI-249380 metabolism. Notably, as dasatinib metabolism is CYP3A4-dependent, the metabolism of [18F]-SKI-249380 may be altered by inhibitors and inducers of cytochrome P450 isoenzyme CYP3A4. The acceptability of medications and other substances used by the patient will be determined by the study investigators.
  • Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [18F]-SKI-249380 injection and blood draws.)
  • Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
  • Hepatic: from assays obtained <2 weeks prior to study enrollment
  • Bilirubin > 1.5 x institutional upper limit of normal (ULN)
  • AST/ALT >2.5 x ULN
  • Albumin < 2 g/dl
  • GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN.
  • Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained <2 weeks prior to study enrollment
  • Acute major illness (e.g., unstable cardiovascular condition, etc.)

Treatment and study plan

[18F]-SKI-249380

Radiation

PET/CT scan

Procedure

PET scans will be performed immediately, at approximately 90 minutes, and optionally at approximately 3 hours after injection of the radiotracer. This includes an initial 30-minute PET scanning period, performed. At each subsequent time-point, a 30 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A 30-45 minute scanning time-period is typical for clinical PET studies. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point.

Blood draws

Other

Blood will be drawn at the multiple time points for pharmacokinetic & metabolite analyses of 18F-SKI-249380. We anticipate these time points to be approximately 1, 5, 15, 30, and 90 minutes and 3 hours (optional), post-injection.

Primary outcomes

  1. pharmacokinetics

    Time frame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection

    This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.

Secondary outcomes

  1. metabolism

    Time frame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection

    This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.

  2. biodistribution

    Time frame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection

    This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.

  3. radiation dosimetry

    Time frame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection

    This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2013
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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