Skip to content

SPECT/CT-Guided Radiotherapy Planning to Reduce Arm Swelling Risk After Breast Cancer Surgery: A Double-Blind Randomized Trial

Impact of SPECT/CT lymphoscintigraphy-based radiotherapy planning for reducing incidental dose to arm draining lymph nodal region vs. standard planning on lymphedema incidence in early breast cancer patients post BCS-A Double blind randomized controlled trial - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094117
Enrollment
110
Registered
2025-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Modified Radiotherapy Plan: Modified Radiotherapy plan using information obtained by SPECT/Lymphoscintigraphy scan in early breast cancer patients followed by 6 months of follow up Cont

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Unilateral Breast cancer 2.Post breast conservation surgery 3.Adequate axillary lymphnode dissection(atleast 10 nodes dissected) 4.Clinically T1/2 N0/1M0, Patients planned only for whole-breast radiation with or without tumour bed boost and Either post upfront surgery and Margins free a. Pathologically N0 disease and ALND Negative b. SLNB positive (1-2) with ALND negative with no high-risk features c. pN1with 1-2 nodes positive with no high-risk features (high-risk features such as Lymphovascular space invasion or extra nodal extension or Grade 3 or pT2 with Hormone receptor negative) Or post-NACT (NACT given due to delay in surgery/ TNBC) d. cT1/2N0 with ypT1/2N0 on ALND 5.Postive SPECT scan uptake in the arm draining lymph node 6.Dose constraints to arm draining node is acheived without compromising on the already set target volume coverage and constraints to normal OAR

Exclusion criteria

Exclusion criteria: 1. Bilateral breast cancer/ recurrent breast cancer 2. Previous radiation therapy to chest wall 3. Active infection in local site, i.e., arm. 4. Predisposing conditions to Lymphedema and lymphadenitis 5. Pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
Modified RT plan reduces the incidence of lymphedema compared to the standard RT plan by limiting the incidental unplanned radiation dose to SPECT/CT identified arm draining lymph node/s/ region.Timepoint: at 6 months post-radiotherapy

Secondary

MeasureTime frame
1.comparison of the quality of life (LyQLI) score between the two arms at baseline and at 6 months post radiotherapy 2.comparison of the incidence of lymphedema (any grade) between the two arms at 1 year and 3 years post radiotherapy 3.comparison of any local or regional nodal or distant recurrence between 2 arms at 6 months, 1 year and 3 years post radiotherapy Timepoint: 6 months, 1 year and 3 years

Countries

India

Contacts

Public ContactDr Gunaseelan K

Department of Radiation oncology, Regional cancer centre, Jawaharlal Institute of Postgraduate Medical Education & Research,

gunapgi@gmail.com8589815977

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 25, 2026