Clinical trial · Observational
Prospective Study of Clinically Nonfunctioning Pituitary Adenomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project is the first comprehensive prospective study of clinically non-functioning pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of 100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and do not require surgery; Group II will consist of 250 patients who have pituitary lesions that are symptomatic and require surgery. Patients will be followed with a series of endocrine laboratory testing, physical examinations, testing of quality of life and neurocognitive function before and serially over time either during non-surgical management or after surgery and in some patients before and after radiotherapy (RT). Data on pituitary magnetic resonance imaging (MRI) studies and visual field testing being done over time during follow up as part of clinical care will be collected.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy for CNFA | Radiation | — | UNRESOLVED |
| Surgical intervention for CNFA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group I
- description
- The first group of subjects, Group I, will be followed in Protocol I and are a group of subjects with an apparent clinically nonfunctioning pituitary lesion who will be studied in a prospective study of conservative non-surgical management.
- label
- Group II
- description
- A second group of subjects, Group II, are subjects who are undergoing surgical intervention for CNFA or radiotherapy for CNFA and these subjects will be studied in a prospectively follow up as part of Protocol II.
- interventionNames
- Procedure: Surgical intervention for CNFA
- Radiation: Radiotherapy for CNFA
Primary outcomes (1)
- measure
- Number of patients with pituitary tumor enlargement
- timeFrame
- 5 years
- description
- Tumor enlargement over the study period
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
GROUP I Inclusion Criteria: * adult patients with pituitary lesions that do not require surgical intervention. * pituitary lesion that has been demonstrated on a magnetic resonance imaging (MRI) to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst). * patients with macroadenomas (\> 1 cm) or large microadenomas 6-9 mm. * a prolactin level \< 40 ng/ml. Exclusion Criteria: * presence of visual or neurological deficits due to the tumor, tumor impingement on the optic chiasm and physical or laboratory abnormalities consistent with a biologically active hormone secreting tumor. GROUP II Inclusion Criteria: * adult patients with pituitary lesions that require surgical intervention and are planning on surgery or who had surgery in the past and are now undergoing pituitary radiotherapy. * pre-surgery patients will have a pituitary lesion that has been demonstrated on a MRI to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst) and that is a macroadenoma (\> 1 cm). * presence of visual or neurological deficits due to the tumor or impingement of the tumor on the optic chiasm is permitted. * a prolactin level \< 100 ng/ml if lesion is \> or = 10 mm in size or a prolactin level \< 40 ng/ml if lesion is \< 10 mm in size. * patients with mild/moderate hyperprolactinemia and recommended for dopamine agonist therapy (on the chance that the lesion is truly a prolactinoma) may re-enter the study should they be a dopamine agonist failure and require surgery. * patients with hypopituitarism and no other surgical indication that choose to undergo surgery is permitted.
References
Publications (0)
Data not yet available