Modified Desmopressin (mDesmo) Using Cold-Kit for PET/CT

NCT06962202 | Recruiting DMC

• 3 other identifiers: PGI/IEC/2021/001537TDP/BDTD/59/2021(G)CTRI/2022/08/044615
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of Cushing syndrome (CS) is 1.2-3.2 cases per million per year, of which adrenocorticotropic Hormone (ACTH)-dependent disease comprises approximately 70-80% of cases. Among these, nearly 90% of ACTH-dependent CS are due to pituitary-dependent CS, known as Cushing disease (CD). The management of ACTH-dependent CS relies on distinguishing Cushing disease (or Corticotropinoma) from ectopic Cushing syndrome (ECS) followed by localization of the tumor in the sella. The diagnosis of CD is very challenging, especially when they are microadenomas (\<6 mm). Current imaging techniques, such as magnetic resonance imaging (MRI), have limitations in accurately delineating (sensitivity 60%) these tumors. Even if the lesion is detected inside the pituitary, the functionality of the tumor is questionable, as there can be innocent pituitary tumors which actually are not the cause of Cushing syndrome in a particular case. The diagnosis gets more complex with the fact that 10% of the ECS cases are reported to have an incidental non-functioning pituitary tumor, this can complicate the diagnosis of ECS. Though the localizing accuracy of bilateral inferior petrosal sinus sampling (BIPSS) is 90%, the lateralization (40-70%) of corticotropinoma (whether the lesion is located on the right or left side) based on BIPSS is still questionable. These challenges contribute to the fact that in approximately 30% of cases of CD, the source of ACTH excess remains occult. The lack of information on accurate localization and lateralization of corticotropinoma leads to reduced remission rates after surgery. Therefore, novel approaches to diagnosing Cushing disease are needed. We have developed a novel radiopharmaceutical Gallium-68- 1,4,7,10-tetraazacyclododecane-N,N',N',N'-tetraacetic acid-modified desmopressin (68Ga-DOTA-mDesmo) for Positron Emission Tomography/Computed Tomography (PET/CT). This radiopharmaceutical has the potential to selectively target the overexpressed V1b receptors in patients diagnosed with Cushing disease. The clinical studies demonstrated 100% diagnostic accuracy of 68Ga-DOTA-mDesmo PET/CT in delineating corticotropinomas, surpassing the accuracy of CE-MRI and BIPSS, regardless of adenoma size. However, the small sample size and regional patient recruitment may affect the generalizability of the results. The project aims to assess the diagnostic sensitivity and specificity of 68Ga-DOTA-mDesmo in a diverse Cushing syndrome population. This will lead to development and validation of a superior, non-invasive diagnostic modality for accurate corticotropinoma delineation, aiding neuro-navigation during surgery and potentially improving treatment outcomes for ACTH-dependent Cushing syndrome.

Conditions

Cushing Syndrome

Keywords

ACTH; bilateral inferior petrosal sinus sampling; Corticotropinoma; transsphenoidal surgery; PET/CT

Outcome Measures

Primary Outcomes (1)

• PET/CT Imaging with Ga-68mDesmo

  Precise localization of corticotropinoma (ACTH secreting tiny adenoma in pituitary)

  one day

Study Arms (1)

Patients with cushing syndrome (CS) characterized by excessive cortisol secretion in the body

To detect and localize the tumor responsible for ACTH-dependent CS. For deleneation of small tumors within the pituitary. Ga-68mDesmo will be injected to enable PET/CT imaging. Ga-68 is a positron emitter.

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 Pts with Cushing Syndrome and 5 control patients

You may qualify if:

• Patients diagnosed with endogenous Cushing's syndrome
• Patients in the age group of 5 to 75 years.
• Patients willing to give informed consent.

You may not qualify if:

• Patient with exogenous exposure to steroids
• Ongoing pregnancy
• Severe comorbid conditions that may interfere with the study.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Ministry of Science and Technology, India: collaborator

Study Sites (1)

Post Graduate Institute of Medical Sciences

Chandigarh, 160012, India

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical samples for histopathological examination fpr correlation with imaging data

MeSH Terms

Conditions

Cushing Syndrome; Pituitary ACTH Hypersecretion

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Rama Walia, DM, Endocrinology

CONTACT

+911722754757; ramawaliapgimer@gmail.com

Jaya Shukla, Prof, Ph.D

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: August 15, 2022
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)