Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT01916135
Eligibility Criteria:
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.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT01916135
Study Brief:
Protocol Section:
NCT01916135