| CTRI Number |
CTRI/2023/03/051025 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
12/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of somatostatin receptor imaging in patients with metastatic breast cancer |
Scientific Title of Study
Modification(s)
|
Somatostatin receptor (SSTR) imaging with 68Ga-DOTATATE PET/CT and its comparison with 18F-FDG PET/CT in patients with estrogen receptor positive (ER positive) metastatic breast cancer (mBC) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandrasekhar Bal |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 59-A, Thyroid Clinic, Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029.
South
DELHI
110029
India |
| Phone |
91-9013775659 |
| Fax |
|
| Email |
csbal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandrasekhar Bal |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 59-A, Thyroid Clinic, Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029.
South
DELHI
110029
India |
| Phone |
91-9013775659 |
| Fax |
|
| Email |
csbal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kunal Ramesh Chandekar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 59-A, Thyroid Clinic, Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029.
South
DELHI
110029
India |
| Phone |
91-9988108048 |
| Fax |
|
| Email |
kunal.chandekar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Ansari Nagar, New Delhi - 110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrasekhar Bal |
AIIMS |
Room number 59-A, Thyroid Clinic, Department of Nuclear Medicine, All India Institute of Medical Sciences, New Delhi - 110029.
South
DELHI |
91-9013775659
csbal@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Drug - 68Ga-DOTATATE |
68Ga-DOTATATE will be injected intravenously at a dose of approximately 111 MBq, around 60 minutes before PET/CT scan acquisition. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Biopsy proven estrogen receptor positive metastatic breast cancer
2. Patients who have undergone 18F-FDG PET/CT for staging/re-staging within the last 3 weeks
3. At least one site of known active disease on imaging within 3 months
4. If a woman is of childbearing potential, a negative urine pregnancy test before administration of SSTR-targeted PET radiotracer would be mandatory. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating females
2. Patients who refuse to give written informed consent
3. Unable to give informed consent or withdrawal of consent any point of time
4. Recent anti-cancer chemotherapy/surgery in less than four weeks or radiotherapy in less than eight weeks
5. Use of long-acting SSTR-targeting agents (example: lanreotide) within 28 days of SSTR-targeted imaging
6. Use of short-acting SSTR-targeting agents (example: sandostatin) within 24 hours of SSTR-targeted imaging
7. Concurrent primary malignancy other than known metastatic breast cancer, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study
8. Subjects with allergy/hypersensitivity to SSTR-targeted imaging agents
9. Current use of high-dose glucocorticoids (≥ 20 mg prednisone per day or equivalent)
10. Active serious infection not controlled by antibiotics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
68Ga-DOTATATE PET/CT imaging
(Assessment of 68Ga-DOTATATE PET/CT imaging to detect lesions in patients with estrogen receptor positive metastatic breast cancer) |
45 minutes to 1 hour from time of injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
15/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Breast cancer is the most commonly diagnosed malignancy worldwide and is the leading cause of cancer-related mortality in women. Hormone receptor status is an important biomarker in breast cancer influencing management strategy. Majority (~70-75%) of breast cancers are reported to be ER+. The mortality of breast cancer correlates with disease extent. The presence of distant metastases is associated with poor survival outcomes. The median five-year survival rate in ER+ mBC is less than 30%, suggesting the need for newer diagnostic and therapeutic techniques to improve patient outcomes in this population. Identification of specific tumor-associated antigens and receptors has led to a paradigm shift in the fields of molecular imaging and targeted cancer therapy. Immunohistochemistry studies have reported SSTR expression in breast cancer tissue samples with higher rates of expression in ER+ breast cancer. There is a dearth of published literature evaluating the role of SSTR-targeted PET imaging in ER+ breast cancer patients. This phase II trial will determine if SSTR-targeted imaging with 68Ga-DOTATATE PET/CT can visualize malignancy in patients with ER+ mBC. The results of this study will also guide the feasibility of SSTR-targeted radionuclide therapy in progressive ER+ mBC patients having limited therapeutic options. |