Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 1, 2027 → Dec 1, 2029
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 160 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Dec 1, 2027 to Dec 1, 2029
    • Study completion pushed from Apr 1, 2028 to Apr 1, 2030
  2. Re-verified, no change to tracked fields
  3. Re-verified, no change to tracked fields
  4. Minor Eligibility criteria expanded, about 14 words
    • Study description expanded, about 13 words
  5. 2 versions Re-verified since Dec 6, 2025, no change to tracked fieldsv155-v156
Show 44 earlier versionsHide 44 earlier versions
  1. Minor Study description shortened, about 4 wordsv154
  2. Minor Study description expanded, about 9 wordsv153
  3. Minor Enrollment target: 77 to 80v152
  4. 6 versions Re-verified since Sep 27, 2024, no change to tracked fieldsv146-v151
  5. Minor Start date changed from estimate of Sep 29, 2024 to Sep 23, 2024v145
  6. Minor Start date: Sep 26, 2024 to Sep 29, 2024v144
  7. Minor Start date: Sep 25, 2024 to Sep 26, 2024v143
  8. Minor Start date: Sep 24, 2024 to Sep 25, 2024v142
  9. Minor Start date: Sep 19, 2024 to Sep 24, 2024v141
  10. Minor Start date: Sep 18, 2024 to Sep 19, 2024v140
  11. Minor Start date: Sep 17, 2024 to Sep 18, 2024v139
  12. Minor Start date: Sep 16, 2024 to Sep 17, 2024v138
  13. Minor Start date: Sep 15, 2024 to Sep 16, 2024v137
  14. Minor Start date: Sep 12, 2024 to Sep 15, 2024v136
  15. Minor Start date: Sep 11, 2024 to Sep 12, 2024v135
  16. Minor Start date: Sep 10, 2024 to Sep 11, 2024v134
  17. Minor Start date: Sep 9, 2024 to Sep 10, 2024v133
  18. Minor Start date: Sep 5, 2024 to Sep 9, 2024v132
  19. Minor Start date: Sep 4, 2024 to Sep 5, 2024v131
  20. Minor Start date: Sep 3, 2024 to Sep 4, 2024v130
  21. Minor Start date: Sep 2, 2024 to Sep 3, 2024v129
  22. Minor Start date: Sep 1, 2024 to Sep 2, 2024v128
  23. Minor Start date: Aug 29, 2024 to Sep 1, 2024v127
  24. Minor Start date: Aug 27, 2024 to Aug 29, 2024v126
  25. Minor Start date: Aug 26, 2024 to Aug 27, 2024v125
  26. Minor Start date: Aug 25, 2024 to Aug 26, 2024v124
  27. Minor Start date: Aug 22, 2024 to Aug 25, 2024v123
  28. Minor Start date: Aug 21, 2024 to Aug 22, 2024v122
  29. Minor Start date: Aug 20, 2024 to Aug 21, 2024v121
  30. Minor Start date: Aug 19, 2024 to Aug 20, 2024v120
  31. Minor Start date: Aug 18, 2024 to Aug 19, 2024v119
  32. Minor Start date: Aug 15, 2024 to Aug 18, 2024v118
  33. Minor Start date: Aug 14, 2024 to Aug 15, 2024v117
  34. Minor Start date: Aug 13, 2024 to Aug 14, 2024v116
  35. Minor Start date: Aug 12, 2024 to Aug 13, 2024v115
  36. Minor Start date: Aug 11, 2024 to Aug 12, 2024v114
  37. Minor Start date: Aug 8, 2024 to Aug 11, 2024v113
  38. Minor Start date: Aug 7, 2024 to Aug 8, 2024v112
  39. Minor Start date: Aug 6, 2024 to Aug 7, 2024v111
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: The adrenal glands are 2 small organs that sit on top of each kidney. They release hormones; these are chemicals that control how the body works. Tumors on or outside the adrenal glands are called functional if they release hormones; they are called nonfunctional if they do not. Doctors who treat adrenal tumors need to know which type a person has. Researchers want to find better ways to learn whether an adrenal tumor is functional. Objective: To see if a new radioactive tracer (\[68Ga\]Ga-PentixaFor) can make it easier to identify functional adrenal tumors with positron emission tomography (PET) scans. Eligibility: People aged 18 years and older with 1 or more adrenal tumors. They must have increased levels of the hormones aldosterone or cortisol. They must also be enrolled in at least 1 other related NIH study (protocols 19-DK-0066, 18-CH-0031, or 09-C-0242). Design: Participants will be screened. They may have imaging scans. Their ability to perform normal activities will be reviewed. Participants will have one PET scan with the study tracer. The tracer will be given through a tube attached to a needle inserted into a vein. Participants will receive the tracer 1 hour before the scan. They will lie still on a bed while a machine captures images of the inside of their body. The scan will take 45 to 90 minutes. Participants heart rate, blood pressure, and rate of breathing will be checked before, during, and after the scan. Participants will have a follow-up visit 3 days after their scan. This visit can be by phone, email, or in person.
Trial Details
NCT Number NCT06246357
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)
Hyperaldosteronism, Hypercortisolism, Cushing s Syndrome
Related terms Adenoma, Cushing Syndrome, Hyperaldosteronism
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov