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|NCT02069080 : Imaging CXCR4 Expression in Subjects With Cancer Using 64 Cu-Plerixafor|
|Ages||Min: 18 Years Max: N/A|
- INCLUSION CRITERIA:
Subjects (greater than or equal to18 years of age) with cancer; at least 1 detectable
solid tumor of greater than or equal to 1.5 cm in diameter found outside of the vertebral
bodies, liver, gallbladder, kidney, and bladder; and, with the exception of adrenocortical
carcinoma, preexisting tumor sample(s) of the cancer obtained since the first detection of
the current occurrence/recurrence of disease are eligible to participate in the screening
portion of the study.
Subjects of reproductive potential are eligible to enter the study if they agree to use 2
forms of contraception 3 weeks prior to the study start and 1 month after the
administration of 64Cu-plerixafor, such as:
- Hormonal contraception.
- Male or female condoms with or without a spermicide.
- Diaphragm or cervical cap with a spermicide.
- Intrauterine device.
Male subjects may commence contraception beginning at the time of infusion of
Subjects who are known to meet Study Phase exclusion criteria during the screening period
may be excluded from entering the Study Phase.
Individuals who meet any of the following criteria are not eligible to participate in the
1. Karnofsky Performance Scale Index (KPSI) < 70.
2. Women who are pregnant or lactating.
3. History of life-threatening cardiac arrhythmia.
4. Absolute neutrophil count < 1000/microliters.
5. Platelet count < 100,000/microliters.
6. Alanine transaminase, aspartate aminotransferase, alkaline phosphatase, or bilirubin
levels greater than or equal to 4 times the upper limits of normal, or a calculated
creatinine clearance rate of less than or equal to 50 mL/min.
7. Treatment with plerixafor or any imaging agent with a radioisotope or labeled
molecule administered < 10 half-lives prior to administration of 64Cu-plerixafor.
8. Research radiation exposure over the past 12 months, which if added to the radiation
exposure in this study, exceeds 5 rem.
9. Allergy to plerixafor.
10. Severe claustrophobia unresponsive to anxiolytics.
11. Weight over 325 pounds.
12. History of any other illness or condition which, in the investigator s opinion, may
substantially increase the risk associated with the subject s participation in the
study, or may compromise the scientific objectives.
Co-enrollment in other trials that involve the infusion of radioactive isotopes/molecules
for research purposes or plerixafor is prohibited.
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