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This study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 ([18F]FNP-59) to image the adrenal gland. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.
Groups 2 & 3 used hormone manipulation using information gathered from Group 1 which identified radiation dosimetry and optimal uptake time.
Group 4 (added to the study later) includes participants with known adrenal pathology. They will not have study associated hormone manipulation.
All groups will be given a radio-tracer and PET/CT scans.
The researchers believe that a fluorine-18 analogue of NP-59, [18F]FNP-59, would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone (Group 2) | Experimental | Participants will undergo an FNP-59 scan on day 0 in the am. Participants will then take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. Participants will then have a second FNP-59 scan on day 4 in the am. |
|
| Cosyntropin (Group 3) | Experimental | Participants will undergo an FNP-59 scan on day 0 in the am. On day 4 the participant will arrive for imaging. Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur. |
|
| Adrenal pathology (Group 4) | Experimental | Whole-body PET/CT scans will be done on 4 patients at 1 hr and the other 4 patients at 6 hours. All the patients will have a whole-body PET/CT scan at 3 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone (Group 2) | Drug | Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation | SUV will be reported. Both maximal and average SUVs will be calculated | Day 0, Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI) | Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake. | Day 4 |
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Inclusion Criteria (Groups 2 & 3):
Exclusion Criteria (Groups 2 & 3):
Inclusion Criteria (Group 4):
Exclusion Criteria (Group 4):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jim Pool | Contact | 734-615-7391 | jampool@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin L Viglianti, M.D, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Cosyntropin (Group 3) | Drug | Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur. |
|
| PET/CT Scan with FNP-59 | Combination Product | FNP-59, a radiotracer, is administered for PET/CT scans. |
|
| BAMF Health, Inc. | Completed | Grand Rapids | Michigan | 49503 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D003366 | Cosyntropin |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000324 | Adrenocorticotropic Hormone |
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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