| CTRI Number |
CTRI/2022/08/044615 [Registered on: 03/08/2022] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cushings disease imaging |
|
Scientific Title of Study
|
mDesmo Cold kit for PET imaging to localize ACTH dependent Cushing syndrome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaya Shukla |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research
Chandigarh CHANDIGARH 160012 India |
| Phone |
01722756724 |
| Fax |
|
| Email |
shuklajaya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jaya Shukla |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research
Chandigarh CHANDIGARH 160012 India |
| Phone |
01722756724 |
| Fax |
|
| Email |
shuklajaya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rama Walia |
| Designation |
Assiociate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Endocrinology, Post Graduate Institute of Medical Education and Research
Chandigarh CHANDIGARH 160012 India |
| Phone |
|
| Fax |
|
| Email |
ramawalia@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Biomedical Device and Technology Development (BDTD), DST India |
|
|
Primary Sponsor
|
| Name |
Biomedical Device and Technology Development BDTD DST India |
| Address |
GOVERNMENT OF INDIA
MINISTRY OF SCIENCE and TECHNOLOGY
DEPARTMENT OF SCIENCE and TECHNOLOGY
TECHNOLOGY BHAVAN, NEW MEHRAULI ROAD,
NEW DELHI – 110 016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| B J Madan Co |
B J Madan & Co.
Space No 2, 2nd Floor,
C- 110/2, Naraina Industrial Area,
Phase 1, Delhi 110028
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaya Shukla |
Post Graduate Institute of Medical Education and Research |
Department of Nuclear Medicine Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh Chandigarh CHANDIGARH |
01722756724
shuklajaya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D093||Carcinoma in situ of thyroid and other endocrine glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
Not applicable
No molecule is currently available globally, this ready to use formulation seems very promising. 68Ga-mDesmo PET/CT imaging will delineate the corticotropinoma from EAS without further performing invasive and costly test like BIPSS. It will also provide surgeons the requisite information for intra-operative tumor navigation |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with endogenous Cushing’s syndrome
2.Patients in the age group of 5 to 75 years.
3.Patients willing to give consent.
|
|
| ExclusionCriteria |
| Details |
1.Patient with exogenous exposure to steroids
2.Ongoing pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PET/CT imaging to provide functional as well as anatomical information for intra-operative tumor navigation and preservation of normal pituitary. |
Single time point.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diagnostic outcome will benefit in precision surgery of pitutiary micro-adenoma |
Single point |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cushing’s
syndrome (CS) is one of the most enigmatic endocrine disorders. It is important
to confirm the ACTH dependent hypercortisolism and distinguishing Cushing’s
disease from ectopic CS. Most of the ACTH dependent CS are caused by Cushing’s
disease, of which majority are due to microadenoma being less than 6 mm. Visualizing
tumors within 10 mm pituitary and confirming its functional status is
challenging. Long-term remission/cure is determined by
the correct functional and anatomical delineation of corticotropinoma (pituitary-tumor).
The treatment of choice in Cushing’s disease is
pituitary microsurgery. However, pituitary-tumor is not well delineated within
the sella in 30-40% using currently available investigations especially MRI and
inferior petrosal sinus sampling, which affects intra-operative navigation for
selective adenomectomy and influence remission rate.
Now we have developed
a non-radioactive (cold kit) formulation. So that the same may be available to
all hospital based radiopharmacy for quick and a facile synthesis of PET tracer,
Ga-68 mDesmo, for lateralizing pituitary adenoma (Cushing’s disease) and differential
diagnosis of ACTH-releasing pituitary adenoma (Cushing’s disease) from the of
ectopic ACTH-secreting tumors by non-invasive molecular imaging (PET/CT).
|